description: This is a specialized resource that defines the characteristics and capabilities of a device. package_name: hl7.fhir.r5.examples derivation: specialization name: DeviceDefinition type: DeviceDefinition elements: description: {isModifier: false, short: Additional information to describe the device, type: markdown, mustSupport: false, isSummary: false, index: 0} deviceName: isModifier: false short: The name or names of the device as given by the manufacturer index: 14 type: BackboneElement mustSupport: false array: true elements: name: {isModifier: false, short: A name that is used to refer to the device, type: string, mustSupport: false, isSummary: false, index: 15} type: isModifier: false short: registered-name | user-friendly-name | patient-reported-name type: code mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-nametype|5.0.0-snapshot1'} isSummary: false index: 16 required: [name, type] isSummary: false shelfLifeStorage: {isModifier: false, short: Shelf Life and storage information, type: ProductShelfLife, mustSupport: false, array: true, isSummary: false, index: 45} packaging: isModifier: false short: Information about the packaging of the device, i.e. how the device is packaged type: BackboneElement mustSupport: false array: true isSummary: false index: 25 elements: identifier: {isModifier: false, short: Business identifier of the packaged medication, type: Identifier, mustSupport: false, isSummary: false, index: 26} type: {isModifier: false, short: A code that defines the specific type of packaging, type: CodeableConcept, mustSupport: false, isSummary: false, index: 27} count: {isModifier: false, short: The number of items contained in the package (devices or sub-packages), type: integer, mustSupport: false, isSummary: false, index: 28} distributor: isModifier: false short: An organization that distributes the packaged device type: BackboneElement mustSupport: false array: true isSummary: false index: 29 elements: name: {isModifier: false, short: Distributor's human-readable name, type: string, mustSupport: false, isSummary: false, index: 30} organizationReference: isModifier: false short: Distributor as an Organization resource refers: ['http://hl7.org/fhir/StructureDefinition/Organization'] type: Reference mustSupport: false array: true isSummary: false index: 31 udiDeviceIdentifier: isModifier: false short: Unique Device Identifier (UDI) Barcode string on the packaging index: 32 type: BackboneElement mustSupport: false array: true elements: deviceIdentifier: {isModifier: false, short: Identifier to be associated with every instance for issuer and jurisdiction, type: string, mustSupport: false, isSummary: false, index: 33} issuer: {isModifier: false, short: The organization that assigns the identifier algorithm, type: uri, mustSupport: false, isSummary: false, index: 34} jurisdiction: {isModifier: false, short: The jurisdiction to which the deviceIdentifier applies, type: uri, mustSupport: false, isSummary: false, index: 35} marketDistribution: isModifier: false short: Indicates whether and when the device is available on the market type: BackboneElement mustSupport: false isSummary: false index: 36 elements: marketPeriod: {isModifier: false, short: Begin and end dates for the commercial distribution of the device, type: Period, mustSupport: false, isSummary: false, index: 37} subJurisdiction: {isModifier: false, short: National state or territory where the device is commercialized, type: uri, mustSupport: false, isSummary: false, index: 38} required: [issuer, deviceIdentifier, jurisdiction] isSummary: false packaging: elementReference: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition', elements, packaging] isModifier: false short: Allows packages within packages mustSupport: false array: true isSummary: false index: 39 property: isModifier: false short: The potential, valid configuration settings of a device, e.g., regulation status, time properties index: 47 type: BackboneElement mustSupport: false array: true elements: valueQuantity: {isModifier: false, short: Property value - as a code or quantity, type: Quantity, mustSupport: false, choiceOf: value, isSummary: false, index: 51} value: isModifier: false short: Property value - as a code or quantity mustSupport: false choices: [valueQuantity, valueCodeableConcept, valueString, valueBoolean, valueInteger, valueRange, valueAttachment] isSummary: false index: 50 valueString: {isModifier: false, short: Property value - as a code or quantity, type: string, mustSupport: false, choiceOf: value, isSummary: false, index: 53} valueBoolean: {isModifier: false, short: Property value - as a code or quantity, type: boolean, mustSupport: false, choiceOf: value, isSummary: false, index: 54} type: {isModifier: false, short: Code that specifies the property, type: CodeableConcept, mustSupport: false, isSummary: false, index: 48} valueCodeableConcept: {isModifier: false, short: Property value - as a code or quantity, type: CodeableConcept, mustSupport: false, choiceOf: value, isSummary: false, index: 52} valueRange: {isModifier: false, short: Property value - as a code or quantity, type: Range, mustSupport: false, choiceOf: value, isSummary: false, index: 56} valueInteger: {isModifier: false, short: Property value - as a code or quantity, type: integer, mustSupport: false, choiceOf: value, isSummary: false, index: 55} valueAttachment: {isModifier: false, short: Property value - as a code or quantity, type: Attachment, mustSupport: false, choiceOf: value, isSummary: false, index: 57} required: [type] isSummary: false manufacturerString: {isModifier: false, short: Name of device manufacturer, type: string, mustSupport: false, choiceOf: manufacturer, isSummary: false, index: 12} partNumber: {isModifier: false, short: The part number or catalog number of the device, type: string, mustSupport: false, isSummary: false, index: 9} modelNumber: {isModifier: false, short: The catalog or model number for the device for example as defined by the manufacturer, type: string, mustSupport: false, isSummary: false, index: 17} udiDeviceIdentifier: isModifier: false short: Unique Device Identifier (UDI) Barcode string index: 2 type: BackboneElement mustSupport: false array: true elements: deviceIdentifier: {isModifier: false, short: The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier, type: string, mustSupport: false, isSummary: false, index: 3} issuer: {isModifier: false, short: The organization that assigns the identifier algorithm, type: uri, mustSupport: false, isSummary: false, index: 4} jurisdiction: {isModifier: false, short: The jurisdiction to which the deviceIdentifier applies, type: uri, mustSupport: false, isSummary: false, index: 5} marketDistribution: isModifier: false short: Indicates whether and when the device is available on the market index: 6 type: BackboneElement mustSupport: false array: true elements: marketPeriod: {isModifier: false, short: Begin and end dates for the commercial distribution of the device, type: Period, mustSupport: false, isSummary: false, index: 7} subJurisdiction: {isModifier: false, short: National state or territory where the device is commercialized, type: uri, mustSupport: false, isSummary: false, index: 8} required: [marketPeriod, subJurisdiction] isSummary: false required: [issuer, deviceIdentifier, jurisdiction] isSummary: false productionIdentifierInUDI: isModifier: false short: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version type: code mustSupport: false array: true binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0-snapshot1'} isSummary: false index: 69 manufacturerReference: isModifier: false short: Name of device manufacturer refers: ['http://hl7.org/fhir/StructureDefinition/Organization'] type: Reference mustSupport: false choiceOf: manufacturer isSummary: false index: 13 guideline: isModifier: false short: Information aimed at providing directions for the usage of this model of device type: BackboneElement mustSupport: false isSummary: false index: 70 elements: useContext: {isModifier: false, short: The circumstances that form the setting for using the device, type: UsageContext, mustSupport: false, array: true, isSummary: false, index: 71} usageInstruction: {isModifier: false, short: Detailed written and visual directions for the user on how to use the device, type: markdown, mustSupport: false, isSummary: false, index: 72} relatedArtifact: {isModifier: false, short: A source of information or reference for this guideline, type: RelatedArtifact, mustSupport: false, array: true, isSummary: false, index: 73} indication: {isModifier: false, short: A clinical condition for which the device was designed to be used, type: CodeableReference, mustSupport: false, array: true, isSummary: false, index: 74} contraindication: {isModifier: false, short: A specific situation when a device should not be used because it may cause harm, type: CodeableReference, mustSupport: false, array: true, isSummary: false, index: 75} warning: {isModifier: false, short: Specific hazard alert information that a user needs to know before using the device, type: CodeableReference, mustSupport: false, array: true, isSummary: false, index: 76} intendedUse: {isModifier: false, short: A description of the general purpose or medical use of the device or its function, type: string, mustSupport: false, isSummary: false, index: 77} specialization: {isModifier: false, short: 'The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication', type: RelatedArtifact, mustSupport: false, array: true, isSummary: false, index: 21} chargeItem: isModifier: false short: Billing code or reference associated with the device index: 82 type: BackboneElement mustSupport: false array: true elements: chargeItemCode: {isModifier: false, short: The code or reference for the charge item, type: CodeableReference, mustSupport: false, isSummary: false, index: 83} count: {isModifier: false, short: Coefficient applicable to the billing code, type: Quantity, mustSupport: false, isSummary: false, index: 84} effectivePeriod: {isModifier: false, short: A specific time period in which this charge item applies, type: Period, mustSupport: false, isSummary: false, index: 85} useContext: {isModifier: false, short: The context to which this charge item applies, type: UsageContext, mustSupport: false, array: true, isSummary: false, index: 86} required: [chargeItemCode, count] isSummary: false parentDevice: isModifier: false short: The parent device it can be part of refers: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition'] type: Reference mustSupport: false isSummary: true index: 64 classification: isModifier: false short: What kind of device or device system this is index: 18 type: BackboneElement mustSupport: false array: true elements: type: isModifier: false short: A classification or risk class of the device model type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-type'} isSummary: false index: 19 justification: {isModifier: false, short: Further information qualifying this classification of the device model, type: RelatedArtifact, mustSupport: false, array: true, isSummary: false, index: 20} required: [type] isSummary: false note: {isModifier: false, short: Device notes and comments, type: Annotation, mustSupport: false, array: true, isSummary: false, index: 63} languageCode: {isModifier: false, short: Language code for the human-readable text strings produced by the device (all supported), type: CodeableConcept, mustSupport: false, array: true, isSummary: false, index: 46} link: isModifier: false short: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device index: 60 type: BackboneElement mustSupport: false array: true elements: relation: isModifier: false short: The type indicates the relationship of the related device to the device instance type: Coding mustSupport: false binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/devicedefinition-relationtype'} isSummary: false index: 61 relatedDevice: {isModifier: false, short: A reference to the linked device, type: CodeableReference, mustSupport: false, isSummary: false, index: 62} required: [relatedDevice, relation] isSummary: false safety: isModifier: false short: Safety characteristics of the device type: CodeableConcept mustSupport: false array: true binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-safety'} isSummary: true index: 44 hasPart: isModifier: false short: A device, part of the current one index: 22 type: BackboneElement mustSupport: false array: true elements: reference: isModifier: false short: Reference to the part refers: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition'] type: Reference mustSupport: false isSummary: false index: 23 count: {isModifier: false, short: Number of occurrences of the part, type: integer, mustSupport: false, isSummary: false, index: 24} required: [reference] isSummary: false material: isModifier: false short: A substance used to create the material(s) of which the device is made index: 65 type: BackboneElement mustSupport: false array: true elements: substance: {isModifier: false, short: 'A relevant substance that the device contains, may contain, or is made of', type: CodeableConcept, mustSupport: false, isSummary: false, index: 66} alternate: {isModifier: false, short: Indicates an alternative material of the device, type: boolean, mustSupport: false, isSummary: false, index: 67} allergenicIndicator: {isModifier: false, short: Whether the substance is a known or suspected allergen, type: boolean, mustSupport: false, isSummary: false, index: 68} required: [substance] isSummary: false identifier: {isModifier: false, short: Instance identifier, type: Identifier, mustSupport: false, array: true, isSummary: false, index: 1} manufacturer: isModifier: false short: Name of device manufacturer mustSupport: false choices: [manufacturerString, manufacturerReference] isSummary: false index: 11 version: isModifier: false short: The version of the device or software index: 40 type: BackboneElement mustSupport: false array: true elements: type: {isModifier: false, short: 'The type of the device version, e.g. manufacturer, approved, internal', type: CodeableConcept, mustSupport: false, isSummary: false, index: 41} component: {isModifier: false, short: The hardware or software module of the device to which the version applies, type: Identifier, mustSupport: false, isSummary: false, index: 42} value: {isModifier: false, short: The version text, type: string, mustSupport: false, isSummary: false, index: 43} required: [value] isSummary: false contact: {isModifier: false, short: Details for human/organization for support, type: ContactPoint, mustSupport: false, array: true, isSummary: false, index: 59} owner: isModifier: false short: Organization responsible for device refers: ['http://hl7.org/fhir/StructureDefinition/Organization'] type: Reference mustSupport: false isSummary: false index: 58 correctiveAction: isModifier: false short: Tracking of latest field safety corrective action type: BackboneElement mustSupport: false isSummary: false index: 78 elements: recall: {isModifier: false, short: Whether the corrective action was a recall, type: boolean, mustSupport: false, isSummary: false, index: 79} scope: isModifier: false short: model | lot-numbers | serial-numbers type: code mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0-snapshot1'} isSummary: false index: 80 period: {isModifier: false, short: Start and end dates of the corrective action, type: Period, mustSupport: false, isSummary: false, index: 81} required: [recall, period] package_version: 5.0.0-snapshot1 class: resource kind: resource url: http://hl7.org/fhir/StructureDefinition/DeviceDefinition base: http://hl7.org/fhir/StructureDefinition/DomainResource version: 5.0.0-snapshot1