8.18 Resource DeviceDefinition - Content

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition	TU		DomainResource	An instance of a medical-related component of a medical device Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension Interfaces Implemented: CanonicalResource
description		0..1	markdown	Additional information to describe the device
identifier	Σ	0..*	Identifier	Instance identifier
udiDeviceIdentifier		0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier		1..1	string	The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
issuer		1..1	uri	The organization that assigns the identifier algorithm
jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies
marketDistribution		0..*	BackboneElement	Indicates whether and when the device is available on the market
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
regulatoryIdentifier		0..*	BackboneElement	Regulatory identifier(s) associated with this device
type		1..1	code	basic | master | license Binding: Device Definition Regulatory Identifier Type (Required)
deviceIdentifier		1..1	string	The identifier itself
issuer		1..1	uri	The organization that issued this identifier
jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies
partNumber		0..1	string	The part number or catalog number of the device
manufacturer	Σ	0..1	Reference(Organization)	Name of device manufacturer
deviceName	Σ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
name	Σ	1..1	string	A name that is used to refer to the device
type	Σ	1..1	CodeableConcept	registered-name | user-friendly-name | patient-reported-name Binding: Device Name Type (Extensible)
modelNumber	Σ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
classification	Σ	0..*	BackboneElement	What kind of device or device system this is
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: Device Type (Example)
justification		0..*	RelatedArtifact	Further information qualifying this classification of the device model
conformsTo	Σ	0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
category	Σ	0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance Binding: Device Specification Category (Example)
specification	Σ	1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: Device Specification Type (Example)
version	Σ	0..*	string	The specific form or variant of the standard, specification or formal guidance
source		0..*	RelatedArtifact	Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
hasPart	Σ	0..*	BackboneElement	A device, part of the current one
reference	Σ	1..1	Reference(DeviceDefinition)	Reference to the part
count		0..1	integer	Number of occurrences of the part
packaging		0..*	BackboneElement	Information about the packaging of the device, i.e. how the device is packaged
identifier		0..1	Identifier	Business identifier of the packaged medication
type		0..1	CodeableConcept	A code that defines the specific type of packaging
count		0..1	integer	The number of items contained in the package (devices or sub-packages)
distributor		0..*	BackboneElement	An organization that distributes the packaged device
name		0..1	string	Distributor's human-readable name
organizationReference		0..*	Reference(Organization)	Distributor as an Organization resource
udiDeviceIdentifier		0..*	see udiDeviceIdentifier	Unique Device Identifier (UDI) Barcode string on the packaging
packaging		0..*	see packaging	Allows packages within packages
deviceVersion		0..*	BackboneElement	The version of the device or software
type		0..1	CodeableConcept	The type of the device version, e.g. manufacturer, approved, internal
component		0..1	Identifier	The hardware or software module of the device to which the version applies
value		1..1	string	The version text
safety	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: Device Safety (Example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
property		0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: Device Property Type (Example)
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
link		0..*	BackboneElement	An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
relation		1..1	Coding	The type indicates the relationship of the related device to the device instance Binding: Device Definition Relation Type (Extensible)
relatedDevice		1..1	CodeableReference(DeviceDefinition)	A reference to the linked device
note		0..*	Annotation	Device notes and comments
material		0..*	BackboneElement	A substance used to create the material(s) of which the device is made
substance		1..1	CodeableConcept	A relevant substance that the device contains, may contain, or is made of Binding: Substance Code (Example)
alternate		0..1	boolean	Indicates an alternative material of the device
allergenicIndicator		0..1	boolean	Whether the substance is a known or suspected allergen
productionIdentifierInUDI		0..*	CodeableConcept	lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: Device Production Identifier In UDI (Extensible)
guideline		0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
useContext		0..*	UsageContext	The circumstances that form the setting for using the device
usageInstruction		0..1	markdown	Detailed written and visual directions for the user on how to use the device
relatedArtifact		0..*	RelatedArtifact	A source of information or reference for this guideline
indication		0..*	CodeableConcept	A clinical condition for which the device was designed to be used
contraindication		0..*	CodeableConcept	A specific situation when a device should not be used because it may cause harm
warning		0..*	CodeableConcept	Specific hazard alert information that a user needs to know before using the device
intendedUse		0..1	string	A description of the general purpose or medical use of the device or its function
correctiveAction		0..1	BackboneElement	Tracking of latest field safety corrective action
recall		1..1	boolean	Whether the corrective action was a recall
scope		0..1	code	model | lot-numbers | serial-numbers Binding: Device Corrective Action Scope (Required)
period		1..1	Period	Start and end dates of the corrective action
chargeItem		0..*	BackboneElement	Billing code or reference associated with the device
chargeItemCode		1..1	CodeableReference(ChargeItemDefinition)	The code or reference for the charge item
count		1..1	Quantity	Coefficient applicable to the billing code
effectivePeriod		0..1	Period	A specific time period in which this charge item applies
useContext		0..*	UsageContext	The context to which this charge item applies
Documentation for this format

See the Extensions for this resource

<DeviceDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <description value="[markdown]"/><!-- 0..1 Additional information to describe the device -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier -->
  <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  <marketDistribution>  <!-- 0..* Indicates whether and when the device is available on the market -->
   <marketPeriod><!-- 1..1 Period Begin and end dates for the commercial distribution of the device --></marketPeriod>
   <subJurisdiction value="[uri]"/><!-- 1..1 National state or territory where the device is commercialized -->
  </marketDistribution>
 </udiDeviceIdentifier>
 <regulatoryIdentifier>  <!-- 0..* Regulatory identifier(s) associated with this device -->
  <type value="[code]"/><!-- 1..1 basic | master | license -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier itself -->
  <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
 </regulatoryIdentifier>
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer>
 <deviceName>  <!-- 0..* The name or names of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 A name that is used to refer to the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
 </deviceName>
 <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer -->
 <classification>  <!-- 0..* What kind of device or device system this is -->
  <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type>
  <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification>
 </classification>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification>
  <version value="[string]"/><!-- 0..* The specific form or variant of the standard, specification or formal guidance -->
  <source><!-- 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance --></source>
 </conformsTo>
 <hasPart>  <!-- 0..* A device, part of the current one -->
  <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference>
  <count value="[integer]"/><!-- 0..1 Number of occurrences of the part -->
 </hasPart>
 <packaging>  <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged -->
  <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier>
  <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type>
  <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) -->
  <distributor>  <!-- 0..* An organization that distributes the packaged device -->
   <name value="[string]"/><!-- 0..1 Distributor's human-readable name -->
   <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <deviceVersion>  <!-- 0..* The version of the device or software -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <link>  <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device -->
  <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation>
  <relatedDevice><!-- 1..1 CodeableReference(DeviceDefinition) A reference to the linked device --></relatedDevice>
 </link>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
 <productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI>
 <guideline>  <!-- 0..1 Information aimed at providing directions for the usage of this model of device -->
  <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext>
  <usageInstruction value="[markdown]"/><!-- 0..1 Detailed written and visual directions for the user on how to use the device -->
  <relatedArtifact><!-- 0..* RelatedArtifact A source of information or reference for this guideline --></relatedArtifact>
  <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning>
  <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function -->
 </guideline>
 <correctiveAction>  <!-- 0..1 Tracking of latest field safety corrective action -->
  <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall -->
  <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers -->
  <period><!-- 1..1 Period Start and end dates of the  corrective action --></period>
 </correctiveAction>
 <chargeItem>  <!-- 0..* Billing code or reference associated with the device -->
  <chargeItemCode><!-- 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item --></chargeItemCode>
  <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count>
  <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod>
  <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext>
 </chargeItem>
</DeviceDefinition>

{
  "resourceType" : "DeviceDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "description" : "<markdown>", // Additional information to describe the device
  "identifier" : [{ Identifier }], // Instance identifier
  "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>", // R!  The jurisdiction to which the deviceIdentifier applies
    "marketDistribution" : [{ // Indicates whether and when the device is available on the market
      "marketPeriod" : { Period }, // R!  Begin and end dates for the commercial distribution of the device
      "subJurisdiction" : "<uri>" // R!  National state or territory where the device is commercialized
    }]
  }],
  "regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
    "type" : "<code>", // R!  basic | master | license
    "deviceIdentifier" : "<string>", // R!  The identifier itself
    "issuer" : "<uri>", // R!  The organization that issued this identifier
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  "partNumber" : "<string>", // The part number or catalog number of the device
  "manufacturer" : { Reference(Organization) }, // Name of device manufacturer
  "deviceName" : [{ // The name or names of the device as given by the manufacturer
    "name" : "<string>", // R!  A name that is used to refer to the device
    "type" : { CodeableConcept } // R!  registered-name | user-friendly-name | patient-reported-name
  }],
  "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
  "classification" : [{ // What kind of device or device system this is
    "type" : { CodeableConcept }, // R!  A classification or risk class of the device model
    "justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    "version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
    "source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  }],
  "hasPart" : [{ // A device, part of the current one
    "reference" : { Reference(DeviceDefinition) }, // R!  Reference to the part
    "count" : <integer> // Number of occurrences of the part
  }],
  "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
    "identifier" : { Identifier }, // Business identifier of the packaged medication
    "type" : { CodeableConcept }, // A code that defines the specific type of packaging
    "count" : <integer>, // The number of items contained in the package (devices or sub-packages)
    "distributor" : [{ // An organization that distributes the packaged device
      "name" : "<string>", // Distributor's human-readable name
      "organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "deviceVersion" : [{ // The version of the device or software
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "value" : "<string>" // R!  The version text
  }],
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    "relation" : { Coding }, // R!  The type indicates the relationship of the related device to the device instance
    "relatedDevice" : { CodeableReference(DeviceDefinition) } // R!  A reference to the linked device
  }],
  "note" : [{ Annotation }], // Device notes and comments
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  A relevant substance that the device contains, may contain, or is made of
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }],
  "productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  "guideline" : { // Information aimed at providing directions for the usage of this model of device
    "useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
    "usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
    "relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
    "indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
    "intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
  },
  "correctiveAction" : { // Tracking of latest field safety corrective action
    "recall" : <boolean>, // R!  Whether the corrective action was a recall
    "scope" : "<code>", // model | lot-numbers | serial-numbers
    "period" : { Period } // R!  Start and end dates of the  corrective action
  },
  "chargeItem" : [{ // Billing code or reference associated with the device
    "chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R!  The code or reference for the charge item
    "count" : { Quantity }, // R!  Coefficient applicable to the billing code
    "effectivePeriod" : { Period }, // A specific time period in which this charge item applies
    "useContext" : [{ UsageContext }] // The context to which this charge item applies
  }]
}

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:DeviceDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:description [ markdown ] ; # 0..1 Additional information to describe the device
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
    fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market
      fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device
      fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized
    ] ... ) ;
  ] ... ) ;
  fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device
    fhir:type [ code ] ; # 1..1 basic | master | license
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier itself
    fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifier
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ] ... ) ;
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer
  fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer
    fhir:name [ string ] ; # 1..1 A name that is used to refer to the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
  ] ... ) ;
  fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:classification ( [ # 0..* What kind of device or device system this is
    fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model
    fhir:justification  ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    fhir:version  ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance
    fhir:source  ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  ] ... ) ;
  fhir:hasPart ( [ # 0..* A device, part of the current one
    fhir:reference [ Reference(DeviceDefinition) ] ; # 1..1 Reference to the part
    fhir:count [ integer ] ; # 0..1 Number of occurrences of the part
  ] ... ) ;
  fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication
    fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging
    fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:distributor ( [ # 0..* An organization that distributes the packaged device
      fhir:name [ string ] ; # 0..1 Distributor's human-readable name
      fhir:organizationReference  ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource
    ] ... ) ;
    fhir:udiDeviceIdentifier  ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
    fhir:packaging  ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages
  ] ... ) ;
  fhir:deviceVersion ( [ # 0..* The version of the device or software
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device
  fhir:shelfLifeStorage  ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information
  fhir:languageCode  ( [ CodeableConcept ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device
  fhir:contact  ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support
  fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:relatedDevice [ CodeableReference(DeviceDefinition) ] ; # 1..1 A reference to the linked device
  ] ... ) ;
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device
    fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen
  ] ... ) ;
  fhir:productionIdentifierInUDI  ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device
    fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline
    fhir:indication  ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used
    fhir:contraindication  ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:warning  ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function
  ] ;
  fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action
    fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall
    fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers
    fhir:period [ Period ] ; # 1..1 Start and end dates of the  corrective action
  ] ;
  fhir:chargeItem ( [ # 0..* Billing code or reference associated with the device
    fhir:chargeItemCode [ CodeableReference(ChargeItemDefinition) ] ; # 1..1 The code or reference for the charge item
    fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code
    fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies
  ] ... ) ;
]

Changes from both R4 and R4B

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition	TU		DomainResource	An instance of a medical-related component of a medical device Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension Interfaces Implemented: CanonicalResource
description		0..1	markdown	Additional information to describe the device
identifier	Σ	0..*	Identifier	Instance identifier
udiDeviceIdentifier		0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier		1..1	string	The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
issuer		1..1	uri	The organization that assigns the identifier algorithm
jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies
marketDistribution		0..*	BackboneElement	Indicates whether and when the device is available on the market
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
regulatoryIdentifier		0..*	BackboneElement	Regulatory identifier(s) associated with this device
type		1..1	code	basic | master | license Binding: Device Definition Regulatory Identifier Type (Required)
deviceIdentifier		1..1	string	The identifier itself
issuer		1..1	uri	The organization that issued this identifier
jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies
partNumber		0..1	string	The part number or catalog number of the device
manufacturer	Σ	0..1	Reference(Organization)	Name of device manufacturer
deviceName	Σ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
name	Σ	1..1	string	A name that is used to refer to the device
type	Σ	1..1	CodeableConcept	registered-name | user-friendly-name | patient-reported-name Binding: Device Name Type (Extensible)
modelNumber	Σ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
classification	Σ	0..*	BackboneElement	What kind of device or device system this is
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: Device Type (Example)
justification		0..*	RelatedArtifact	Further information qualifying this classification of the device model
conformsTo	Σ	0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
category	Σ	0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance Binding: Device Specification Category (Example)
specification	Σ	1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: Device Specification Type (Example)
version	Σ	0..*	string	The specific form or variant of the standard, specification or formal guidance
source		0..*	RelatedArtifact	Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
hasPart	Σ	0..*	BackboneElement	A device, part of the current one
reference	Σ	1..1	Reference(DeviceDefinition)	Reference to the part
count		0..1	integer	Number of occurrences of the part
packaging		0..*	BackboneElement	Information about the packaging of the device, i.e. how the device is packaged
identifier		0..1	Identifier	Business identifier of the packaged medication
type		0..1	CodeableConcept	A code that defines the specific type of packaging
count		0..1	integer	The number of items contained in the package (devices or sub-packages)
distributor		0..*	BackboneElement	An organization that distributes the packaged device
name		0..1	string	Distributor's human-readable name
organizationReference		0..*	Reference(Organization)	Distributor as an Organization resource
udiDeviceIdentifier		0..*	see udiDeviceIdentifier	Unique Device Identifier (UDI) Barcode string on the packaging
packaging		0..*	see packaging	Allows packages within packages
deviceVersion		0..*	BackboneElement	The version of the device or software
type		0..1	CodeableConcept	The type of the device version, e.g. manufacturer, approved, internal
component		0..1	Identifier	The hardware or software module of the device to which the version applies
value		1..1	string	The version text
safety	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: Device Safety (Example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
property		0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: Device Property Type (Example)
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
link		0..*	BackboneElement	An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
relation		1..1	Coding	The type indicates the relationship of the related device to the device instance Binding: Device Definition Relation Type (Extensible)
relatedDevice		1..1	CodeableReference(DeviceDefinition)	A reference to the linked device
note		0..*	Annotation	Device notes and comments
material		0..*	BackboneElement	A substance used to create the material(s) of which the device is made
substance		1..1	CodeableConcept	A relevant substance that the device contains, may contain, or is made of Binding: Substance Code (Example)
alternate		0..1	boolean	Indicates an alternative material of the device
allergenicIndicator		0..1	boolean	Whether the substance is a known or suspected allergen
productionIdentifierInUDI		0..*	CodeableConcept	lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: Device Production Identifier In UDI (Extensible)
guideline		0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
useContext		0..*	UsageContext	The circumstances that form the setting for using the device
usageInstruction		0..1	markdown	Detailed written and visual directions for the user on how to use the device
relatedArtifact		0..*	RelatedArtifact	A source of information or reference for this guideline
indication		0..*	CodeableConcept	A clinical condition for which the device was designed to be used
contraindication		0..*	CodeableConcept	A specific situation when a device should not be used because it may cause harm
warning		0..*	CodeableConcept	Specific hazard alert information that a user needs to know before using the device
intendedUse		0..1	string	A description of the general purpose or medical use of the device or its function
correctiveAction		0..1	BackboneElement	Tracking of latest field safety corrective action
recall		1..1	boolean	Whether the corrective action was a recall
scope		0..1	code	model | lot-numbers | serial-numbers Binding: Device Corrective Action Scope (Required)
period		1..1	Period	Start and end dates of the corrective action
chargeItem		0..*	BackboneElement	Billing code or reference associated with the device
chargeItemCode		1..1	CodeableReference(ChargeItemDefinition)	The code or reference for the charge item
count		1..1	Quantity	Coefficient applicable to the billing code
effectivePeriod		0..1	Period	A specific time period in which this charge item applies
useContext		0..*	UsageContext	The context to which this charge item applies
Documentation for this format

See the Extensions for this resource

<DeviceDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <description value="[markdown]"/><!-- 0..1 Additional information to describe the device -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier -->
  <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  <marketDistribution>  <!-- 0..* Indicates whether and when the device is available on the market -->
   <marketPeriod><!-- 1..1 Period Begin and end dates for the commercial distribution of the device --></marketPeriod>
   <subJurisdiction value="[uri]"/><!-- 1..1 National state or territory where the device is commercialized -->
  </marketDistribution>
 </udiDeviceIdentifier>
 <regulatoryIdentifier>  <!-- 0..* Regulatory identifier(s) associated with this device -->
  <type value="[code]"/><!-- 1..1 basic | master | license -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier itself -->
  <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
 </regulatoryIdentifier>
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer>
 <deviceName>  <!-- 0..* The name or names of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 A name that is used to refer to the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
 </deviceName>
 <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer -->
 <classification>  <!-- 0..* What kind of device or device system this is -->
  <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type>
  <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification>
 </classification>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification>
  <version value="[string]"/><!-- 0..* The specific form or variant of the standard, specification or formal guidance -->
  <source><!-- 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance --></source>
 </conformsTo>
 <hasPart>  <!-- 0..* A device, part of the current one -->
  <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference>
  <count value="[integer]"/><!-- 0..1 Number of occurrences of the part -->
 </hasPart>
 <packaging>  <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged -->
  <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier>
  <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type>
  <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) -->
  <distributor>  <!-- 0..* An organization that distributes the packaged device -->
   <name value="[string]"/><!-- 0..1 Distributor's human-readable name -->
   <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <deviceVersion>  <!-- 0..* The version of the device or software -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <link>  <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device -->
  <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation>
  <relatedDevice><!-- 1..1 CodeableReference(DeviceDefinition) A reference to the linked device --></relatedDevice>
 </link>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
 <productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI>
 <guideline>  <!-- 0..1 Information aimed at providing directions for the usage of this model of device -->
  <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext>
  <usageInstruction value="[markdown]"/><!-- 0..1 Detailed written and visual directions for the user on how to use the device -->
  <relatedArtifact><!-- 0..* RelatedArtifact A source of information or reference for this guideline --></relatedArtifact>
  <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning>
  <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function -->
 </guideline>
 <correctiveAction>  <!-- 0..1 Tracking of latest field safety corrective action -->
  <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall -->
  <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers -->
  <period><!-- 1..1 Period Start and end dates of the  corrective action --></period>
 </correctiveAction>
 <chargeItem>  <!-- 0..* Billing code or reference associated with the device -->
  <chargeItemCode><!-- 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item --></chargeItemCode>
  <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count>
  <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod>
  <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext>
 </chargeItem>
</DeviceDefinition>

{
  "resourceType" : "DeviceDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "description" : "<markdown>", // Additional information to describe the device
  "identifier" : [{ Identifier }], // Instance identifier
  "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>", // R!  The jurisdiction to which the deviceIdentifier applies
    "marketDistribution" : [{ // Indicates whether and when the device is available on the market
      "marketPeriod" : { Period }, // R!  Begin and end dates for the commercial distribution of the device
      "subJurisdiction" : "<uri>" // R!  National state or territory where the device is commercialized
    }]
  }],
  "regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
    "type" : "<code>", // R!  basic | master | license
    "deviceIdentifier" : "<string>", // R!  The identifier itself
    "issuer" : "<uri>", // R!  The organization that issued this identifier
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  "partNumber" : "<string>", // The part number or catalog number of the device
  "manufacturer" : { Reference(Organization) }, // Name of device manufacturer
  "deviceName" : [{ // The name or names of the device as given by the manufacturer
    "name" : "<string>", // R!  A name that is used to refer to the device
    "type" : { CodeableConcept } // R!  registered-name | user-friendly-name | patient-reported-name
  }],
  "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
  "classification" : [{ // What kind of device or device system this is
    "type" : { CodeableConcept }, // R!  A classification or risk class of the device model
    "justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    "version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
    "source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  }],
  "hasPart" : [{ // A device, part of the current one
    "reference" : { Reference(DeviceDefinition) }, // R!  Reference to the part
    "count" : <integer> // Number of occurrences of the part
  }],
  "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
    "identifier" : { Identifier }, // Business identifier of the packaged medication
    "type" : { CodeableConcept }, // A code that defines the specific type of packaging
    "count" : <integer>, // The number of items contained in the package (devices or sub-packages)
    "distributor" : [{ // An organization that distributes the packaged device
      "name" : "<string>", // Distributor's human-readable name
      "organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "deviceVersion" : [{ // The version of the device or software
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "value" : "<string>" // R!  The version text
  }],
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    "relation" : { Coding }, // R!  The type indicates the relationship of the related device to the device instance
    "relatedDevice" : { CodeableReference(DeviceDefinition) } // R!  A reference to the linked device
  }],
  "note" : [{ Annotation }], // Device notes and comments
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  A relevant substance that the device contains, may contain, or is made of
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }],
  "productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  "guideline" : { // Information aimed at providing directions for the usage of this model of device
    "useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
    "usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
    "relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
    "indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
    "intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
  },
  "correctiveAction" : { // Tracking of latest field safety corrective action
    "recall" : <boolean>, // R!  Whether the corrective action was a recall
    "scope" : "<code>", // model | lot-numbers | serial-numbers
    "period" : { Period } // R!  Start and end dates of the  corrective action
  },
  "chargeItem" : [{ // Billing code or reference associated with the device
    "chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R!  The code or reference for the charge item
    "count" : { Quantity }, // R!  Coefficient applicable to the billing code
    "effectivePeriod" : { Period }, // A specific time period in which this charge item applies
    "useContext" : [{ UsageContext }] // The context to which this charge item applies
  }]
}

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:DeviceDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:description [ markdown ] ; # 0..1 Additional information to describe the device
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
    fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market
      fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device
      fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized
    ] ... ) ;
  ] ... ) ;
  fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device
    fhir:type [ code ] ; # 1..1 basic | master | license
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier itself
    fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifier
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ] ... ) ;
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer
  fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer
    fhir:name [ string ] ; # 1..1 A name that is used to refer to the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
  ] ... ) ;
  fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:classification ( [ # 0..* What kind of device or device system this is
    fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model
    fhir:justification  ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    fhir:version  ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance
    fhir:source  ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  ] ... ) ;
  fhir:hasPart ( [ # 0..* A device, part of the current one
    fhir:reference [ Reference(DeviceDefinition) ] ; # 1..1 Reference to the part
    fhir:count [ integer ] ; # 0..1 Number of occurrences of the part
  ] ... ) ;
  fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication
    fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging
    fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:distributor ( [ # 0..* An organization that distributes the packaged device
      fhir:name [ string ] ; # 0..1 Distributor's human-readable name
      fhir:organizationReference  ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource
    ] ... ) ;
    fhir:udiDeviceIdentifier  ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
    fhir:packaging  ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages
  ] ... ) ;
  fhir:deviceVersion ( [ # 0..* The version of the device or software
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device
  fhir:shelfLifeStorage  ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information
  fhir:languageCode  ( [ CodeableConcept ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device
  fhir:contact  ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support
  fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:relatedDevice [ CodeableReference(DeviceDefinition) ] ; # 1..1 A reference to the linked device
  ] ... ) ;
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device
    fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen
  ] ... ) ;
  fhir:productionIdentifierInUDI  ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device
    fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline
    fhir:indication  ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used
    fhir:contraindication  ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:warning  ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function
  ] ;
  fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action
    fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall
    fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers
    fhir:period [ Period ] ; # 1..1 Start and end dates of the  corrective action
  ] ;
  fhir:chargeItem ( [ # 0..* Billing code or reference associated with the device
    fhir:chargeItemCode [ CodeableReference(ChargeItemDefinition) ] ; # 1..1 The code or reference for the charge item
    fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code
    fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies
  ] ... ) ;
]

Changes from both R4 and R4B

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.