Order Catalog Implementation Guide
current - CI Build

Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

Resource Profile: DeviceModel Profile

Defining URL:http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel
Version:current
Name:DeviceModel
Title:Device Model
Status:Draft as of 2022-02-20 06:06:45+0100
Definition:

This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices

Publisher:HL7 International - Orders and Observations Work Group
Source Resource:XML / JSON / Turtle

The official URL for this profile is: 

http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from DeviceDefinition

Summary

Mandatory: 0 element (3 nested mandatory elements)
Must-Support: 14 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element DeviceDefinition.classification is sliced based on the value of pattern:type.coding.system

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... CatalogReference 0..*Reference(Catalog Header)Reference to a catalog
URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference
... description S0..1markdownAdditional information to describe the device
... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
.... marketDistribution S0..*BackboneElementIndicates whether and when the device is available on the market
..... marketPeriod
...... start 0..1dateTimeStarting time with inclusive boundary
...... end 0..1dateTimeEnd time with inclusive boundary, if not ongoing
..... subJurisdiction 1..1uriNational state or territory where the device is commercialized
... partNumber S0..1stringThe part number or catalog number of the device
... manufacturer S0..1Reference(Organization)Name of device manufacturer
... deviceName S0..*BackboneElementThe name or names of the device as given by the manufacturer
.... name 1..1stringA name that is used to refer to the device
.... type 1..1coderegistered-name | user-friendly-name | patient-reported-name
... modelNumber S0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... Slices for classification 0..*BackboneElementWhat kind of device or device system this is
Slice: Unordered, Open by pattern:type.coding.system
.... classification:gmdn 0..*BackboneElementGMDN classification
..... type
...... coding
....... system 1..1uriIdentity of the terminology system
Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN
....... code 0..1codeSymbol in syntax defined by the system
....... display 0..1stringRepresentation defined by the system
.... classification:snomed 0..1BackboneElementSNOMED CT
..... type
...... coding
....... system 1..1uriIdentity of the terminology system
Required Pattern: http://snomed.info/sct
.... classification:emdn 0..1BackboneElementEMDN
..... type
...... coding
....... system 1..1uriIdentity of the terminology system
Required Pattern: urn:oid:1.2.250.1.213.2.68
....... code 0..1codeSymbol in syntax defined by the system
....... display 0..1stringRepresentation defined by the system
... hasPart
.... count S0..1integerNumber of occurrences of the part
... packaging
.... type 0..1CodeableConceptA code that defines the specific type of packaging
.... count S0..1integerThe number of items contained in the package (devices or sub-packages)
.... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string on the packaging
..... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
..... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
..... marketDistribution
...... marketPeriod
....... end 0..1dateTimeEnd time with inclusive boundary, if not ongoing
...... subJurisdiction 1..1uriNational state or territory where the device is commercialized
... safety S0..*CodeableConceptSafety characteristics of the device
... property S0..*BackboneElementThe potential, valid configuration settings of a device, e.g., regulation status, time properties
... contact 0..*ContactPointDetails for human/organization for support
... productionIdentifierInUDI 0..*codelot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
... guideline S0..1BackboneElementInformation aimed at providing directions for the usage of this model of device

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... CatalogReference 0..*Reference(Catalog Header)Reference to a catalog
URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... description S0..1markdownAdditional information to describe the device
... identifier S0..*IdentifierInstance identifier
... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
.... marketDistribution S0..*BackboneElementIndicates whether and when the device is available on the market
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... marketPeriod 1..1PeriodBegin and end dates for the commercial distribution of the device
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... start ΣC0..1dateTimeStarting time with inclusive boundary
...... end ΣC0..1dateTimeEnd time with inclusive boundary, if not ongoing
..... subJurisdiction 1..1uriNational state or territory where the device is commercialized
... regulatoryIdentifier 0..*BackboneElementRegulatory identifier(s) associated with this device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1codebasic | master | license
Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type.

.... deviceIdentifier 1..1stringThe identifier itself
.... issuer 1..1uriThe organization that issued this identifier
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
... partNumber S0..1stringThe part number or catalog number of the device
... manufacturer S0..1Reference(Organization)Name of device manufacturer
... deviceName S0..*BackboneElementThe name or names of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringA name that is used to refer to the device
.... type 1..1coderegistered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber S0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... Slices for classification 0..*BackboneElementWhat kind of device or device system this is
Slice: Unordered, Open by pattern:type.coding.system
.... classification:All Slices Content/Rules for all slices
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
.... classification:gmdn 0..*BackboneElementGMDN classification
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ1..1uriIdentity of the terminology system
Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
.... classification:snomed 0..1BackboneElementSNOMED CT
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ1..1uriIdentity of the terminology system
Required Pattern: http://snomed.info/sct
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
.... classification:emdn 0..1BackboneElementEMDN
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ1..1uriIdentity of the terminology system
Required Pattern: urn:oid:1.2.250.1.213.2.68
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
... specialization 0..*RelatedArtifactThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
... hasPart 0..*BackboneElementA device, part of the current one
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... reference 1..1Reference(DeviceDefinition)Reference to the part
.... count S0..1integerNumber of occurrences of the part
... packaging 0..*BackboneElementInformation about the packaging of the device, i.e. how the device is packaged
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... identifier 0..1IdentifierBusiness identifier of the packaged medication
.... type 0..1CodeableConceptA code that defines the specific type of packaging
.... count S0..1integerThe number of items contained in the package (devices or sub-packages)
.... distributor 0..*BackboneElementAn organization that distributes the packaged device
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... name 0..1stringDistributor's human-readable name
..... organizationReference 0..*Reference(Organization)Distributor as an Organization resource
.... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string on the packaging
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
..... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
..... marketDistribution 0..*BackboneElementIndicates whether and when the device is available on the market
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... marketPeriod 1..1PeriodBegin and end dates for the commercial distribution of the device
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... start ΣC0..1dateTimeStarting time with inclusive boundary
....... end ΣC0..1dateTimeEnd time with inclusive boundary, if not ongoing
...... subJurisdiction 1..1uriNational state or territory where the device is commercialized
.... packaging 0..*See packaging (DeviceDefinition)Allows packages within packages
... version 0..*BackboneElementThe version of the device or software
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 0..1CodeableConceptThe type of the device version, e.g. manufacturer, approved, internal
.... component 0..1IdentifierThe hardware or software module of the device to which the version applies
.... value 1..1stringThe version text
... safety SΣ0..*CodeableConceptSafety characteristics of the device
Binding: DeviceSafety (example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... property S0..*BackboneElementThe potential, valid configuration settings of a device, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property
.... value[x] 1..1Property value - as a code or quantity
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueAttachmentAttachment
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... link 0..*BackboneElementAn associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... relation 1..1CodingThe type indicates the relationship of the related device to the device instance
Binding: DeviceDefinitionRelationType (extensible): The type of relation between this and the linked device.

.... relatedDevice 1..1CodeableReference(DeviceDefinition)A reference to the linked device
... note 0..*AnnotationDevice notes and comments
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material 0..*BackboneElementA substance used to create the material(s) of which the device is made
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... substance 1..1CodeableConceptA relevant substance that the device contains, may contain, or is made of
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen
... productionIdentifierInUDI 0..*codelot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier.


... guideline S0..1BackboneElementInformation aimed at providing directions for the usage of this model of device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... useContext 0..*UsageContextThe circumstances that form the setting for using the device
.... usageInstruction 0..1markdownDetailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..*RelatedArtifactA source of information or reference for this guideline
.... indication 0..*CodeableReference(ClinicalUseDefinition)A clinical condition for which the device was designed to be used
.... contraindication 0..*CodeableReference(ClinicalUseDefinition)A specific situation when a device should not be used because it may cause harm
.... warning 0..*CodeableReference(ClinicalUseDefinition)Specific hazard alert information that a user needs to know before using the device
.... intendedUse 0..1stringA description of the general purpose or medical use of the device or its function
... correctiveAction 0..1BackboneElementTracking of latest field safety corrective action
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... recall 1..1booleanWhether the corrective action was a recall
.... scope 0..1codemodel | lot-numbers | serial-numbers
Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action.

.... period 1..1PeriodStart and end dates of the corrective action
... chargeItem 0..*BackboneElementBilling code or reference associated with the device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... chargeItemCode 1..1CodeableReference(ChargeItemDefinition)The code or reference for the charge item
.... count 1..1QuantityCoefficient applicable to the billing code
.... effectivePeriod 0..1PeriodA specific time period in which this charge item applies
.... useContext 0..*UsageContextThe context to which this charge item applies

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... description 0..1markdownAdditional information to describe the device
... identifier 0..*IdentifierInstance identifier
... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... marketDistribution 0..*BackboneElementIndicates whether and when the device is available on the market
... manufacturer 0..1Reference(Organization)Name of device manufacturer
... deviceName 0..*BackboneElementThe name or names of the device as given by the manufacturer
... modelNumber 0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... hasPart 0..*BackboneElementA device, part of the current one
.... count 0..1integerNumber of occurrences of the part
... packaging 0..*BackboneElementInformation about the packaging of the device, i.e. how the device is packaged
.... count 0..1integerThe number of items contained in the package (devices or sub-packages)
.... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string on the packaging
... safety Σ0..*CodeableConceptSafety characteristics of the device
Binding: DeviceSafety (example)
... property 0..*BackboneElementThe potential, valid configuration settings of a device, e.g., regulation status, time properties
... guideline 0..1BackboneElementInformation aimed at providing directions for the usage of this model of device

doco Documentation for this format

This structure is derived from DeviceDefinition

Summary

Mandatory: 0 element (3 nested mandatory elements)
Must-Support: 14 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element DeviceDefinition.classification is sliced based on the value of pattern:type.coding.system

Differential View

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... CatalogReference 0..*Reference(Catalog Header)Reference to a catalog
URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference
... description S0..1markdownAdditional information to describe the device
... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
.... marketDistribution S0..*BackboneElementIndicates whether and when the device is available on the market
..... marketPeriod
...... start 0..1dateTimeStarting time with inclusive boundary
...... end 0..1dateTimeEnd time with inclusive boundary, if not ongoing
..... subJurisdiction 1..1uriNational state or territory where the device is commercialized
... partNumber S0..1stringThe part number or catalog number of the device
... manufacturer S0..1Reference(Organization)Name of device manufacturer
... deviceName S0..*BackboneElementThe name or names of the device as given by the manufacturer
.... name 1..1stringA name that is used to refer to the device
.... type 1..1coderegistered-name | user-friendly-name | patient-reported-name
... modelNumber S0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... Slices for classification 0..*BackboneElementWhat kind of device or device system this is
Slice: Unordered, Open by pattern:type.coding.system
.... classification:gmdn 0..*BackboneElementGMDN classification
..... type
...... coding
....... system 1..1uriIdentity of the terminology system
Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN
....... code 0..1codeSymbol in syntax defined by the system
....... display 0..1stringRepresentation defined by the system
.... classification:snomed 0..1BackboneElementSNOMED CT
..... type
...... coding
....... system 1..1uriIdentity of the terminology system
Required Pattern: http://snomed.info/sct
.... classification:emdn 0..1BackboneElementEMDN
..... type
...... coding
....... system 1..1uriIdentity of the terminology system
Required Pattern: urn:oid:1.2.250.1.213.2.68
....... code 0..1codeSymbol in syntax defined by the system
....... display 0..1stringRepresentation defined by the system
... hasPart
.... count S0..1integerNumber of occurrences of the part
... packaging
.... type 0..1CodeableConceptA code that defines the specific type of packaging
.... count S0..1integerThe number of items contained in the package (devices or sub-packages)
.... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string on the packaging
..... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
..... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
..... marketDistribution
...... marketPeriod
....... end 0..1dateTimeEnd time with inclusive boundary, if not ongoing
...... subJurisdiction 1..1uriNational state or territory where the device is commercialized
... safety S0..*CodeableConceptSafety characteristics of the device
... property S0..*BackboneElementThe potential, valid configuration settings of a device, e.g., regulation status, time properties
... contact 0..*ContactPointDetails for human/organization for support
... productionIdentifierInUDI 0..*codelot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
... guideline S0..1BackboneElementInformation aimed at providing directions for the usage of this model of device

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... CatalogReference 0..*Reference(Catalog Header)Reference to a catalog
URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... description S0..1markdownAdditional information to describe the device
... identifier S0..*IdentifierInstance identifier
... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
.... marketDistribution S0..*BackboneElementIndicates whether and when the device is available on the market
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... marketPeriod 1..1PeriodBegin and end dates for the commercial distribution of the device
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... start ΣC0..1dateTimeStarting time with inclusive boundary
...... end ΣC0..1dateTimeEnd time with inclusive boundary, if not ongoing
..... subJurisdiction 1..1uriNational state or territory where the device is commercialized
... regulatoryIdentifier 0..*BackboneElementRegulatory identifier(s) associated with this device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1codebasic | master | license
Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type.

.... deviceIdentifier 1..1stringThe identifier itself
.... issuer 1..1uriThe organization that issued this identifier
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
... partNumber S0..1stringThe part number or catalog number of the device
... manufacturer S0..1Reference(Organization)Name of device manufacturer
... deviceName S0..*BackboneElementThe name or names of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringA name that is used to refer to the device
.... type 1..1coderegistered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber S0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... Slices for classification 0..*BackboneElementWhat kind of device or device system this is
Slice: Unordered, Open by pattern:type.coding.system
.... classification:All Slices Content/Rules for all slices
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
.... classification:gmdn 0..*BackboneElementGMDN classification
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ1..1uriIdentity of the terminology system
Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
.... classification:snomed 0..1BackboneElementSNOMED CT
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ1..1uriIdentity of the terminology system
Required Pattern: http://snomed.info/sct
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
.... classification:emdn 0..1BackboneElementEMDN
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 1..1CodeableConceptA classification or risk class of the device model
Binding: DeviceType (example): Type of device e.g. according to official classification.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ1..1uriIdentity of the terminology system
Required Pattern: urn:oid:1.2.250.1.213.2.68
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
..... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
... specialization 0..*RelatedArtifactThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
... hasPart 0..*BackboneElementA device, part of the current one
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... reference 1..1Reference(DeviceDefinition)Reference to the part
.... count S0..1integerNumber of occurrences of the part
... packaging 0..*BackboneElementInformation about the packaging of the device, i.e. how the device is packaged
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... identifier 0..1IdentifierBusiness identifier of the packaged medication
.... type 0..1CodeableConceptA code that defines the specific type of packaging
.... count S0..1integerThe number of items contained in the package (devices or sub-packages)
.... distributor 0..*BackboneElementAn organization that distributes the packaged device
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... name 0..1stringDistributor's human-readable name
..... organizationReference 0..*Reference(Organization)Distributor as an Organization resource
.... udiDeviceIdentifier S0..*BackboneElementUnique Device Identifier (UDI) Barcode string on the packaging
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
..... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
..... marketDistribution 0..*BackboneElementIndicates whether and when the device is available on the market
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... marketPeriod