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

• Content
• Detailed Descriptions
• Mappings
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• XML
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• TTL

Resource Profile: DeviceModel Profile

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

Usage:

• Examples for this Resource Profile: DeviceDefinition/example-devicemodel-breast-pump, DeviceDefinition/example-devicemodel-interbody-fusion-system and DeviceDefinition/example-devicemodel-presthetics-accessories

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from DeviceDefinition

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
Slices for extension		0..*	Extension	Extension 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	S	0..1	markdown	Additional information to describe the device
identifier	S	0..*	Identifier	Instance identifier
udiDeviceIdentifier	S	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	S	0..*	BackboneElement	Indicates whether and when the device is available on the market
marketPeriod
start		0..1	dateTime	Starting time with inclusive boundary
end		0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
partNumber	S	0..1	string	The part number or catalog number of the device
manufacturer	S	0..1	Reference(Organization)	Name of device manufacturer
deviceName	S	0..*	BackboneElement	The name or names of the device as given by the manufacturer
name		1..1	string	A name that is used to refer to the device
type		1..1	code	registered-name | user-friendly-name | patient-reported-name
modelNumber	S	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
Slices for classification		0..*	BackboneElement	What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system
classification:gmdn		0..*	BackboneElement	GMDN classification
type
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
classification:snomed		0..1	BackboneElement	SNOMED CT
type
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://snomed.info/sct
classification:emdn		0..1	BackboneElement	EMDN
type
coding
system		1..1	uri	Identity of the terminology system Required Pattern: urn:oid:1.2.250.1.213.2.68
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
hasPart
count	S	0..1	integer	Number of occurrences of the part
packaging
type		0..1	CodeableConcept	A code that defines the specific type of packaging
count	S	0..1	integer	The number of items contained in the package (devices or sub-packages)
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string on the packaging
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
marketPeriod
end		0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
safety	S	0..*	CodeableConcept	Safety characteristics of the device
property	S	0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
contact		0..*	ContactPoint	Details for human/organization for support
productionIdentifierInUDI		0..*	code	lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
guideline	S	0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension 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	?!Σ	0..*	Extension	Extensions that cannot be ignored
description	S	0..1	markdown	Additional information to describe the device
identifier	SΣ	0..*	Identifier	Instance identifier
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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	S	0..*	BackboneElement	Indicates whether and when the device is available on the market
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device
start	ΣC	0..1	dateTime	Starting time with inclusive boundary
end	ΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
partNumber	S	0..1	string	The part number or catalog number of the device
manufacturer	SΣ	0..1	Reference(Organization)	Name of device manufacturer
deviceName	SΣ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	Σ	1..1	string	A name that is used to refer to the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by.
modelNumber	SΣ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
Slices for classification	Σ	0..*	BackboneElement	What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system
classification:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
classification:gmdn	Σ	0..*	BackboneElement	GMDN classification
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
classification:snomed	Σ	0..1	BackboneElement	SNOMED CT
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
classification:emdn	Σ	0..1	BackboneElement	EMDN
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
hasPart	Σ	0..*	BackboneElement	A device, part of the current one
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
reference	Σ	1..1	Reference(DeviceDefinition)	Reference to the part
count	S	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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	A code that defines the specific type of packaging
count	S	0..1	integer	The number of items contained in the package (devices or sub-packages)
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string on the packaging
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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
safety	SΣ	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
property	S	0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: DeviceType (example): Device property type.
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
contact		0..*	ContactPoint	Details for human/organization for support
productionIdentifierInUDI		0..*	code	lot-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	S	0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
DeviceDefinition.deviceName.type	required	DeviceNameType
DeviceDefinition.classification.type	example	DeviceType
DeviceDefinition.classification:gmdn.type	example	DeviceType
DeviceDefinition.classification:snomed.type	example	DeviceType
DeviceDefinition.classification:emdn.type	example	DeviceType
DeviceDefinition.safety	example	DeviceSafety
DeviceDefinition.property.type	example	DeviceType
DeviceDefinition.productionIdentifierInUDI	required	DeviceProductionIdentifierInUDI

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	DeviceDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DeviceDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	DeviceDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	DeviceDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DeviceDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension 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	?!Σ	0..*	Extension	Extensions that cannot be ignored
description	S	0..1	markdown	Additional information to describe the device
identifier	SΣ	0..*	Identifier	Instance identifier
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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	S	0..*	BackboneElement	Indicates whether and when the device is available on the market
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
start	ΣC	0..1	dateTime	Starting time with inclusive boundary
end	ΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
regulatoryIdentifier		0..*	BackboneElement	Regulatory identifier(s) associated with this device
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	code	basic | master | license Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type.
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	S	0..1	string	The part number or catalog number of the device
manufacturer	SΣ	0..1	Reference(Organization)	Name of device manufacturer
deviceName	SΣ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	Σ	1..1	string	A name that is used to refer to the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by.
modelNumber	SΣ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
Slices for classification	Σ	0..*	BackboneElement	What 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..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
justification		0..*	RelatedArtifact	Further information qualifying this classification of the device model
classification:gmdn	Σ	0..*	BackboneElement	GMDN classification
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
justification		0..*	RelatedArtifact	Further information qualifying this classification of the device model
classification:snomed	Σ	0..1	BackboneElement	SNOMED CT
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://snomed.info/sct
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
justification		0..*	RelatedArtifact	Further information qualifying this classification of the device model
classification:emdn	Σ	0..1	BackboneElement	EMDN
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: urn:oid:1.2.250.1.213.2.68
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category	Σ	0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance Binding: DeviceSpecificationCategory (example)
specification	Σ	1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: DeviceSpecificationType (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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
reference	Σ	1..1	Reference(DeviceDefinition)	Reference to the part
count	S	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier		0..1	Identifier	Business identifier of the packaged medication
type		0..1	CodeableConcept	A code that defines the specific type of packaging
count	S	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Distributor's human-readable name
organizationReference		0..*	Reference(Organization)	Distributor as an Organization resource
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string on the packaging
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
start	ΣC	0..1	dateTime	Starting time with inclusive boundary
end	ΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
packaging		0..*	See packaging (DeviceDefinition)	Allows packages within packages
version		0..*	BackboneElement	The version of the device or software
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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	SΣ	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (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	S	0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: DeviceType (example): Device property type.
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relation		1..1	Coding	The 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..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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance		1..1	CodeableConcept	A relevant substance that the device contains, may contain, or is made of
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..*	code	lot-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	S	0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
recall		1..1	boolean	Whether the corrective action was a recall
scope		0..1	code	model | lot-numbers | serial-numbers Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action.
period		1..1	Period	Start and end dates of the corrective action
chargeItem		0..*	BackboneElement	Billing code or reference associated with the device
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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

Terminology Bindings

Path	Conformance	ValueSet
DeviceDefinition.language	required	AllLanguages
DeviceDefinition.regulatoryIdentifier.type	required	DeviceDefinitionRegulatoryIdentifierType
DeviceDefinition.deviceName.type	required	DeviceNameType
DeviceDefinition.classification.type	example	DeviceType
DeviceDefinition.classification:gmdn.type	example	DeviceType
DeviceDefinition.classification:snomed.type	example	DeviceType
DeviceDefinition.classification:emdn.type	example	DeviceType
DeviceDefinition.conformsTo.category	example	DeviceSpecificationCategory
DeviceDefinition.conformsTo.specification	example	DeviceSpecificationType
DeviceDefinition.safety	example	DeviceSafety
DeviceDefinition.property.type	example	DeviceType
DeviceDefinition.link.relation	extensible	DeviceDefinitionRelationType
DeviceDefinition.productionIdentifierInUDI	required	DeviceProductionIdentifierInUDI
DeviceDefinition.correctiveAction.scope	required	DeviceCorrectiveActionScope

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

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:

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

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

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
Slices for extension		0..*	Extension	Extension 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	S	0..1	markdown	Additional information to describe the device
identifier	S	0..*	Identifier	Instance identifier
udiDeviceIdentifier	S	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	S	0..*	BackboneElement	Indicates whether and when the device is available on the market
marketPeriod
start		0..1	dateTime	Starting time with inclusive boundary
end		0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
partNumber	S	0..1	string	The part number or catalog number of the device
manufacturer	S	0..1	Reference(Organization)	Name of device manufacturer
deviceName	S	0..*	BackboneElement	The name or names of the device as given by the manufacturer
name		1..1	string	A name that is used to refer to the device
type		1..1	code	registered-name | user-friendly-name | patient-reported-name
modelNumber	S	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
Slices for classification		0..*	BackboneElement	What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system
classification:gmdn		0..*	BackboneElement	GMDN classification
type
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
classification:snomed		0..1	BackboneElement	SNOMED CT
type
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://snomed.info/sct
classification:emdn		0..1	BackboneElement	EMDN
type
coding
system		1..1	uri	Identity of the terminology system Required Pattern: urn:oid:1.2.250.1.213.2.68
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
hasPart
count	S	0..1	integer	Number of occurrences of the part
packaging
type		0..1	CodeableConcept	A code that defines the specific type of packaging
count	S	0..1	integer	The number of items contained in the package (devices or sub-packages)
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string on the packaging
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
marketPeriod
end		0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
safety	S	0..*	CodeableConcept	Safety characteristics of the device
property	S	0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
contact		0..*	ContactPoint	Details for human/organization for support
productionIdentifierInUDI		0..*	code	lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
guideline	S	0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension 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	?!Σ	0..*	Extension	Extensions that cannot be ignored
description	S	0..1	markdown	Additional information to describe the device
identifier	SΣ	0..*	Identifier	Instance identifier
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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	S	0..*	BackboneElement	Indicates whether and when the device is available on the market
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device
start	ΣC	0..1	dateTime	Starting time with inclusive boundary
end	ΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
subJurisdiction		1..1	uri	National state or territory where the device is commercialized
partNumber	S	0..1	string	The part number or catalog number of the device
manufacturer	SΣ	0..1	Reference(Organization)	Name of device manufacturer
deviceName	SΣ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	Σ	1..1	string	A name that is used to refer to the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by.
modelNumber	SΣ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
Slices for classification	Σ	0..*	BackboneElement	What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system
classification:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
classification:gmdn	Σ	0..*	BackboneElement	GMDN classification
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
classification:snomed	Σ	0..1	BackboneElement	SNOMED CT
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
classification:emdn	Σ	0..1	BackboneElement	EMDN
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification.
hasPart	Σ	0..*	BackboneElement	A device, part of the current one
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
reference	Σ	1..1	Reference(DeviceDefinition)	Reference to the part
count	S	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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	A code that defines the specific type of packaging
count	S	0..1	integer	The number of items contained in the package (devices or sub-packages)
udiDeviceIdentifier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string on the packaging
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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
safety	SΣ	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
property	S	0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: DeviceType (example): Device property type.
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger