description: This is a specialized resource that defines the characteristics and capabilities of a device. package_name: hl7.fhir.r6.examples derivation: specialization name: DeviceDefinition type: DeviceDefinition elements: description: {isModifier: false, short: Natural language description of the DeviceDefinition, type: markdown, mustSupport: false, isSummary: false, index: 14} date: {isModifier: false, short: Date last changed, type: dateTime, mustSupport: false, isSummary: true, index: 11} publisher: {isModifier: false, short: Name of the publisher/steward (organization or individual), type: string, mustSupport: false, isSummary: true, index: 12} approvalDate: {isModifier: false, short: When DeviceDefinition was approved by publisher, type: date, mustSupport: false, isSummary: false, index: 20} deviceName: isModifier: false short: The name or names of the device as given by the manufacturer index: 40 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: true, index: 41} type: isModifier: false short: registered-name | user-friendly-name | patient-reported-name type: CodeableConcept mustSupport: false binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/device-nametype'} isSummary: true index: 42 required: [name, type] isSummary: true jurisdiction: isModifier: false short: Jurisdiction of the authority that maintains the DeviceDefinition (if applicable) type: CodeableConcept mustSupport: false array: true binding: {strength: extensible, valueSet: 'http://terminology.hl7.org/ValueSet/jurisdiction'} isSummary: true index: 16 purpose: {isModifier: false, short: Why this DeviceDefinition is defined, type: markdown, mustSupport: false, isSummary: false, index: 17} shelfLifeStorage: {isModifier: false, short: Shelf Life and storage information, type: ProductShelfLife, mustSupport: false, array: true, isSummary: false, index: 71} 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: 57 elements: identifier: {isModifier: false, short: Business identifier of the packaged medication, type: Identifier, mustSupport: false, isSummary: false, index: 58} type: {isModifier: false, short: A code that defines the specific type of packaging, type: CodeableConcept, mustSupport: false, isSummary: false, index: 59} count: {isModifier: false, short: The number of items contained in the package (devices or sub-packages), type: integer, mustSupport: false, isSummary: false, index: 60} distributor: isModifier: false short: An organization that distributes the packaged device type: BackboneElement mustSupport: false array: true isSummary: false index: 61 elements: name: {isModifier: false, short: Distributor's human-readable name, type: string, mustSupport: false, isSummary: false, index: 62} 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: 63 udiDeviceIdentifier: elementReference: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition', elements, udiDeviceIdentifier] isModifier: false short: Unique Device Identifier (UDI) Barcode string on the packaging mustSupport: false array: true isSummary: false index: 64 packaging: elementReference: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition', elements, packaging] isModifier: false short: Allows packages within packages mustSupport: false array: true isSummary: false index: 65 property: isModifier: false short: Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc index: 73 type: BackboneElement mustSupport: false array: true elements: valueQuantity: {isModifier: false, short: Value of the property, type: Quantity, mustSupport: false, choiceOf: value, isSummary: false, index: 77} value: isModifier: false short: Value of the property mustSupport: false choices: [valueQuantity, valueCodeableConcept, valueString, valueBoolean, valueInteger, valueRange, valueAttachment] isSummary: false index: 76 valueString: {isModifier: false, short: Value of the property, type: string, mustSupport: false, choiceOf: value, isSummary: false, index: 79} valueBoolean: {isModifier: false, short: Value of the property, type: boolean, mustSupport: false, choiceOf: value, isSummary: false, index: 80} type: isModifier: false short: Code that specifies the property being represented type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-property-type'} isSummary: false index: 74 valueCodeableConcept: {isModifier: false, short: Value of the property, type: CodeableConcept, mustSupport: false, choiceOf: value, isSummary: false, index: 78} valueRange: {isModifier: false, short: Value of the property, type: Range, mustSupport: false, choiceOf: value, isSummary: false, index: 82} valueInteger: {isModifier: false, short: Value of the property, type: integer, mustSupport: false, choiceOf: value, isSummary: false, index: 81} valueAttachment: {isModifier: false, short: Value of the property, type: Attachment, mustSupport: false, choiceOf: value, isSummary: false, index: 83} required: [valueString, valueRange, valueAttachment, value, valueBoolean, type, valueCodeableConcept, valueQuantity, valueInteger] isSummary: false outputLanguage: isModifier: false short: Language code for the human-readable text strings produced by the device (all supported) type: code mustSupport: false array: true binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot4'} isSummary: false index: 72 name: {isModifier: false, short: Name for this DeviceDefinition (computer friendly), type: string, mustSupport: false, isSummary: true, index: 7} partNumber: {isModifier: false, short: The part number or catalog number of the device, type: string, mustSupport: false, isSummary: false, index: 23} copyrightLabel: {isModifier: false, short: Copyright holder and year(s), type: string, mustSupport: false, isSummary: false, index: 19} modelNumber: {isModifier: false, short: The catalog or model number for the device for example as defined by the manufacturer, type: string, mustSupport: false, isSummary: true, index: 25} useContext: {isModifier: false, short: The context that the content is intended to support, type: UsageContext, mustSupport: false, array: true, isSummary: true, index: 15} udiDeviceIdentifier: isModifier: false short: Unique Device Identifier (UDI) Barcode string index: 26 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: 27} issuer: {isModifier: false, short: The organization that assigns the identifier algorithm, type: uri, mustSupport: false, isSummary: false, index: 28} jurisdiction: {isModifier: false, short: The jurisdiction to which the deviceIdentifier applies, type: uri, mustSupport: false, isSummary: false, index: 29} marketDistribution: isModifier: false short: Indicates whether and when the device is available on the market index: 30 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: 31} subJurisdiction: {isModifier: false, short: National state or territory where the device is commercialized, type: uri, mustSupport: false, isSummary: false, index: 32} required: [marketPeriod, subJurisdiction] isSummary: false deviceIdentifierSystem: {isModifier: false, short: The namespace for the device identifier value, type: uri, mustSupport: false, isSummary: false, index: 33} required: [issuer, deviceIdentifier, jurisdiction] isSummary: false copyright: {isModifier: false, short: 'Notice about intellectual property ownership, can include restrictions on use', type: markdown, mustSupport: false, isSummary: false, index: 18} versionAlgorithm: isModifier: false short: How to compare versions mustSupport: false choices: [versionAlgorithmString, versionAlgorithmCoding] isSummary: true index: 4 productionIdentifierInUDI: isModifier: false short: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version type: CodeableConcept mustSupport: false array: true binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/device-productidentifierinudi'} isSummary: false index: 95 experimental: {isModifier: false, short: For testing only - never for real usage, type: boolean, mustSupport: false, meaningWhenMissing: 'If absent, this resource is treated as though it is not experimental.', isSummary: true, index: 10} guideline: isModifier: false short: Information aimed at providing directions for the usage of this model of device type: BackboneElement mustSupport: false isSummary: false index: 96 elements: useContext: {isModifier: false, short: The circumstances that form the setting for using the device, type: UsageContext, mustSupport: false, array: true, isSummary: false, index: 97} 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: 98} relatedArtifact: {isModifier: false, short: A source of information or reference for this guideline, type: RelatedArtifact, mustSupport: false, array: true, isSummary: false, index: 99} indication: {isModifier: false, short: A clinical condition for which the device was designed to be used, type: CodeableConcept, mustSupport: false, array: true, isSummary: false, index: 100} contraindication: {isModifier: false, short: A specific situation when a device should not be used because it may cause harm, type: CodeableConcept, mustSupport: false, array: true, isSummary: false, index: 101} warning: {isModifier: false, short: Specific hazard alert information that a user needs to know before using the device, type: CodeableConcept, mustSupport: false, array: true, isSummary: false, index: 102} 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: 103} chargeItem: isModifier: false short: Billing code or reference associated with the device index: 108 type: BackboneElement mustSupport: false array: true elements: chargeItemCode: isModifier: false short: The code or reference for the charge item type: CodeableReference mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/service-uscls'} isSummary: false index: 109 count: {isModifier: false, short: Coefficient applicable to the billing code, type: Quantity, mustSupport: false, isSummary: false, index: 110} effectivePeriod: {isModifier: false, short: A specific time period in which this charge item applies, type: Period, mustSupport: false, isSummary: false, index: 111} useContext: {isModifier: false, short: The context to which this charge item applies, type: UsageContext, mustSupport: false, array: true, isSummary: false, index: 112} required: [chargeItemCode, count] isSummary: false classification: isModifier: false short: What kind of device or device system this is index: 43 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: true index: 44 justification: {isModifier: false, short: Further information qualifying this classification of the device model, type: RelatedArtifact, mustSupport: false, array: true, isSummary: false, index: 45} required: [type] isSummary: true title: {isModifier: false, short: Name for this DeviceDefinition (human friendly), type: string, mustSupport: false, isSummary: true, index: 8} note: {isModifier: false, short: Device notes and comments, type: Annotation, mustSupport: false, array: true, isSummary: false, index: 90} versionAlgorithmCoding: {isModifier: false, short: How to compare versions, type: Coding, mustSupport: false, choiceOf: versionAlgorithm, isSummary: true, index: 6} status: isModifier: true short: 'draft | active | retired | unknown ' index: 9 type: code mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot4'} isModifierReason: This is labeled as "Is Modifier" because applications should not use a retired DeviceDefinition without due consideration isSummary: true 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: 84 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: 85 relatedDevice: isModifier: false short: A reference to the linked device mustSupport: false choices: [relatedDeviceCanonical, relatedDeviceCodeableConcept] isSummary: false index: 87 relatedDeviceCanonical: {isModifier: false, short: A reference to the linked device, type: canonical, mustSupport: false, choiceOf: relatedDevice, isSummary: false, index: 88} relatedDeviceCodeableConcept: {isModifier: false, short: A reference to the linked device, type: CodeableConcept, mustSupport: false, choiceOf: relatedDevice, isSummary: false, index: 89} required: [relatedDeviceCanonical, relatedDevice, relatedDeviceCodeableConcept, 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: 70 hasPart: isModifier: false short: A device, part of the current one index: 51 type: BackboneElement mustSupport: false array: true elements: definition: isModifier: false short: Reference to the part mustSupport: false choices: [definitionCanonical, definitionCodeableConcept] isSummary: true index: 53 definitionCanonical: {isModifier: false, short: Reference to the part, type: canonical, mustSupport: false, choiceOf: definition, isSummary: true, index: 54} definitionCodeableConcept: {isModifier: false, short: Reference to the part, type: CodeableConcept, mustSupport: false, choiceOf: definition, isSummary: true, index: 55} count: {isModifier: false, short: Number of occurrences of the part, type: integer, mustSupport: false, isSummary: false, index: 56} required: [definitionCodeableConcept, definition, definitionCanonical] isSummary: true material: isModifier: false short: A substance used to create the material(s) of which the device is made index: 91 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 binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/substance-code'} isSummary: false index: 92 alternate: {isModifier: false, short: Indicates an alternative material of the device, type: boolean, mustSupport: false, isSummary: false, index: 93} allergenicIndicator: {isModifier: false, short: Whether the substance is a known or suspected allergen, type: boolean, mustSupport: false, isSummary: false, index: 94} required: [substance] isSummary: false conformsTo: isModifier: false short: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device index: 46 type: BackboneElement mustSupport: false array: true elements: category: isModifier: false short: Describes the common type of the standard, specification, or formal guidance type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-specification-category'} isSummary: true index: 47 specification: isModifier: false short: Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-specification-type'} isSummary: true index: 48 version: {isModifier: false, short: 'The specific form or variant of the standard, specification or formal guidance', type: string, mustSupport: false, array: true, isSummary: true, index: 49} source: {isModifier: false, short: 'Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance', type: RelatedArtifact, mustSupport: false, array: true, isSummary: false, index: 50} required: [specification] isSummary: true url: constraint: cnl-1: {human: 'URL should not contain | or # - these characters make processing canonical references problematic', source: 'http://hl7.org/fhir/StructureDefinition/DeviceDefinition', severity: warning, expression: 'exists() implies matches(''^[^|# ]+$'')'} isModifier: false short: Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique) type: uri mustSupport: false isSummary: true index: 0 identifier: {isModifier: false, short: Additional identifier for the DeviceDefinition, type: Identifier, mustSupport: false, array: true, isSummary: true, index: 1} lastReviewDate: {isModifier: false, short: Date on which the asset content was last reviewed by the publisher, type: date, mustSupport: false, isSummary: false, index: 21} manufacturer: isModifier: false short: Name of device manufacturer refers: ['http://hl7.org/fhir/StructureDefinition/Organization'] type: Reference mustSupport: false isSummary: true index: 24 versionAlgorithmString: {isModifier: false, short: How to compare versions, type: string, mustSupport: false, choiceOf: versionAlgorithm, isSummary: true, index: 5} deviceVersion: isModifier: false short: The version of the device or software index: 66 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: 67} component: {isModifier: false, short: The hardware or software module of the device to which the version applies, type: Identifier, mustSupport: false, isSummary: false, index: 68} value: {isModifier: false, short: The version text, type: string, mustSupport: false, isSummary: false, index: 69} required: [value] isSummary: false version: {isModifier: false, short: Business version of the DeviceDefinition, type: string, mustSupport: false, isSummary: true, index: 2} contact: {isModifier: false, short: Contact details for the publisher, type: ContactDetail, mustSupport: false, array: true, isSummary: true, index: 13} correctiveAction: isModifier: false short: Tracking of latest field safety corrective action type: BackboneElement mustSupport: false isSummary: false index: 104 elements: recall: {isModifier: false, short: Whether the corrective action was a recall, type: boolean, mustSupport: false, isSummary: false, index: 105} scope: isModifier: false short: model | lot-numbers | serial-numbers type: code mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-correctiveactionscope|6.0.0-ballot4'} isSummary: false index: 106 period: {isModifier: false, short: Start and end dates of the corrective action, type: Period, mustSupport: false, isSummary: false, index: 107} required: [recall, period] regulatoryIdentifier: isModifier: false short: Regulatory identifier(s) associated with this device index: 34 type: BackboneElement mustSupport: false array: true elements: type: isModifier: false short: basic | master | license type: code mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|6.0.0-ballot4'} isSummary: false index: 35 identifier: {isModifier: false, short: The identifier itself, type: string, mustSupport: false, isSummary: false, index: 36} issuer: {isModifier: false, short: The organization that issued this identifier, type: uri, mustSupport: false, isSummary: false, index: 37} jurisdiction: {isModifier: false, short: Relevant jurisdiction governing the identifier, type: uri, mustSupport: false, isSummary: false, index: 38} identifierSystem: {isModifier: false, short: The namespace for the device identifier value, type: uri, mustSupport: false, isSummary: false, index: 39} required: [issuer, identifier, jurisdiction, type] isSummary: false effectivePeriod: {isModifier: false, short: The effective date range for the DeviceDefinition, type: Period, mustSupport: false, isSummary: true, index: 22} package_version: 6.0.0-ballot4 class: resource kind: resource url: http://hl7.org/fhir/StructureDefinition/DeviceDefinition base: http://hl7.org/fhir/StructureDefinition/DomainResource version: 6.0.0-ballot4 required: [status]