2026 US Quality Core Implementation Guide
0.5.0 - cibuild US

2026 US Quality Core Implementation Guide, published by Office of the National Coordinator for Health Information Technology (ONC). This guide is not an authorized publication; it is the continuous build for version 0.5.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/FHIR/us-quality-core/ and changes regularly. See the Directory of published versions

## Resource Profile: USQualityCoreDevice - Detailed Descriptions

Active as of 2026-05-15

Definitions for the us-quality-core-device resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

0. Device
Definition | A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.
Short | Item used in healthcare
Control | 0..*
Is Modifier | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Device.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Device.udiCarrier
Definition | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
Short | Unique Device Identifier (UDI) Barcode string
Comments | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Device.udiCarrier.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
10. Device.udiCarrier.deviceIdentifier
Definition | The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Short | Mandatory fixed portion of UDI
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | DI
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.status
Definition | Status of the Device availability.
Short | active | inactive | entered-in-error | unknown
Comments | This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.
Control | 0..1
Binding | The codes SHALL be taken from FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 (required to `http://hl7.org/fhir/ValueSet/device-status|4.0.1` ) The availability status of the device.
Type | code
Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Device.type
Definition | The kind or type of device.
Short | The kind or type of device
Control | 0..1
Binding | For example codes, see DeviceType http://hl7.org/fhir/ValueSet/device-type|4.0.1 (example to `http://hl7.org/fhir/ValueSet/device-type|4.0.1` ) Codes to identify medical devices.
Type | CodeableConcept
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Device.patient
Definition | Patient information, If the device is affixed to a person.
Short | Patient to whom Device is affixed
Control | 10..1
Type | Reference(US Quality Core Patient, Patient)
Is Modifier | false
Summary | false
Requirements | If the device is implanted in a patient, then need to associate the device to the patient.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be foundhere

0. Device
2. Device.udiCarrier
Short | Unique Device Identifier (UDI) Barcode string
4. Device.udiCarrier.deviceIdentifier
Short | Mandatory fixed portion of UDI
6. Device.type
Short | The kind or type of device
8. Device.patient
Short | Patient to whom Device is affixed
Control | 1..1
Type | Reference(US Quality Core Patient)

Guidance on how to interpret the contents of this table can be foundhere

0. Device
Definition | A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.
Short | Item used in healthcare
Control | 0..*
Is Modifier | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-3: 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`) dom-4: 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: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) dom-6: A resource should have narrative for robust management (`text.`div`.exists()`)
2. Device.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical id of this artifact
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Control | 0..1
Type | id
Is Modifier | false
Summary | true
4. Device.meta
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. Device.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. Device.language
Definition | The base language in which the resource is written.
Short | Language of the resource content
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages (preferred to `http://hl7.org/fhir/ValueSet/languages|4.0.1` ) A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. Device.text
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Short | Text summary of the resource, for human interpretation
Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Control | 0..1
Type | Narrative
Is Modifier | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
12. Device.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Short | Contained, inline Resources
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Control | 0..*
Type | Resource
Is Modifier | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. Device.extension
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
16. Device.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. Device.identifier
Definition | Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Short | Instance identifier
Comments | The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. Device.definition
Definition | The reference to the definition for the device.
Short | The reference to the definition for the device
Control | 0..1
Type | Reference(DeviceDefinition)
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. Device.udiCarrier
Definition | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
Short | Unique Device Identifier (UDI) Barcode string
Comments | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. Device.udiCarrier.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
26. Device.udiCarrier.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
28. Device.udiCarrier.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
30. Device.udiCarrier.deviceIdentifier
Definition | The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Short | Mandatory fixed portion of UDI
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | DI
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. Device.udiCarrier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Short | UDI Issuing Organization
Control | 0..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Alternate Names | Barcode System
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. Device.udiCarrier.jurisdiction
Definition | The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.
Short | Regional UDI authority
Control | 0..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Requirements | Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. Device.udiCarrier.carrierAIDC
Definition | The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.
Short | UDI Machine Readable Barcode String
Comments | The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1
Type | base64Binary
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Automatic Identification and Data Capture
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. Device.udiCarrier.carrierHRF
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Short | UDI Human Readable Barcode String
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Human Readable Form
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. Device.udiCarrier.entryType
Definition | A coded entry to indicate how the data was entered.
Short | barcode | rfid | manual +
Control | 0..1
Binding | The codes SHALL be taken from UDIEntryType (required to `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` ) Codes to identify how UDI data was entered.
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Requirements | Supports a way to distinguish hand entered from machine read data.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. Device.status
Definition | Status of the Device availability.
Short | active | inactive | entered-in-error | unknown
Comments | This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.
Control | 0..1
Binding | The codes SHALL be taken from FHIRDeviceStatus (required to `http://hl7.org/fhir/ValueSet/device-status|4.0.1` ) The availability status of the device.
Type | code
Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. Device.statusReason
Definition | Reason for the dtatus of the Device availability.
Short | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Control | 0..*
Binding | Unless not suitable, these codes SHALL be taken from FHIRDeviceStatusReason (extensible to `http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1` ) The availability status reason of the device.
Type | CodeableConcept
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. Device.distinctIdentifier
Definition | The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.
Short | The distinct identification string
Comments | For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Alternate Names | Distinct Identification Code (DIC)
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
48. Device.manufacturer
Definition | A name of the manufacturer.
Short | Name of device manufacturer
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
50. Device.manufactureDate
Definition | The date and time when the device was manufactured.
Short | Date when the device was made
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
52. Device.expirationDate
Definition | The date and time beyond which this device is no longer valid or should not be used (if applicable).
Short | Date and time of expiry of this device (if applicable)
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. Device.lotNumber
Definition | Lot number assigned by the manufacturer.
Short | Lot number of manufacture
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. Device.serialNumber
Definition | The serial number assigned by the organization when the device was manufactured.
Short | Serial number assigned by the manufacturer
Comments | Alphanumeric Maximum 20.
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. Device.deviceName
Definition | This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.
Short | The name of the device as given by the manufacturer
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
60. Device.deviceName.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
62. Device.deviceName.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
64. Device.deviceName.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
66. Device.deviceName.name
Definition | The name of the device.
Short | The name of the device
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Alternate Names | Σ
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
68. Device.deviceName.type
Definition | The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
Short | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Control | 1..1
Binding | The codes SHALL be taken from DeviceNameType (required to `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` ) The type of name the device is referred by.
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
70. Device.modelNumber
Definition | The model number for the device.
Short | The model number for the device
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
72. Device.partNumber
Definition | The part number of the device.
Short | The part number of the device
Comments | Alphanumeric Maximum 20.
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. Device.type
Definition | The kind or type of device.
Short | The kind or type of device
Control | 0..1
Binding | For example codes, see DeviceType (example to `http://hl7.org/fhir/ValueSet/device-type|4.0.1` ) Codes to identify medical devices.
Type | CodeableConcept
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. Device.specialization
Definition | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
Short | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. Device.specialization.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
80. Device.specialization.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
82. Device.specialization.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
84. Device.specialization.systemType
Definition | The standard that is used to operate and communicate.
Short | The standard that is used to operate and communicate
Control | 1..1
Type | CodeableConcept
Is Modifier | false
Summary | false
Alternate Names | Σ
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
86. Device.specialization.version
Definition | The version of the standard that is used to operate and communicate.
Short | The version of the standard that is used to operate and communicate
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
88. Device.version
Definition | The actual design of the device or software version running on the device.
Short | The actual design of the device or software version running on the device
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
90. Device.version.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
92. Device.version.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
94. Device.version.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
96. Device.version.type
Definition | The type of the device version.
Short | The type of the device version
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Summary | false
Alternate Names | Σ
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. Device.version.component
Definition | A single component of the device version.
Short | A single component of the device version
Control | 0..1
Type | Identifier
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
100. Device.version.value
Definition | The version text.
Short | The version text
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
102. Device.property
Definition | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
Short | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
104. Device.property.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
106. Device.property.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
108. Device.property.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
110. Device.property.type
Definition | Code that specifies the property DeviceDefinitionPropetyCode (Extensible).
Short | Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Control | 1..1
Type | CodeableConcept
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
112. Device.property.valueQuantity
Definition | Property value as a quantity.
Short | Property value as a quantity
Control | 0..*
Type | Quantity
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
114. Device.property.valueCode
Definition | Property value as a code, e.g., NTP4 (synced to NTP).
Short | Property value as a code, e.g., NTP4 (synced to NTP)
Control | 0..*
Type | CodeableConcept
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
116. Device.patient
Definition | Patient information, If the device is affixed to a person.
Short | Patient to whom Device is affixed
Control | 1..1
Type | Reference(US Quality Core Patient)
Is Modifier | false
Summary | false
Requirements | If the device is implanted in a patient, then need to associate the device to the patient.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. Device.owner
Definition | An organization that is responsible for the provision and ongoing maintenance of the device.
Short | Organization responsible for device
Control | 0..1
Type | Reference(Organization)
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
120. Device.contact
Definition | Contact details for an organization or a particular human that is responsible for the device.
Short | Details for human/organization for support
Comments | used for troubleshooting etc.
Control | 0..*
Type | ContactPoint
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
122. Device.location
Definition | The place where the device can be found.
Short | Where the device is found
Control | 0..1
Type | Reference(Location)
Is Modifier | false
Summary | false
Requirements | Device.location can be used to track device location.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
124. Device.url
Definition | A network address on which the device may be contacted directly.
Short | Network address to contact device
Comments | If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
Control | 0..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
126. Device.note
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element.
Short | Device notes and comments
Control | 0..*
Type | Annotation
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
128. Device.safety
Definition | Provides additional safety characteristics about a medical device. For example devices containing latex.
Short | Safety Characteristics of Device
Control | 0..*
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
130. Device.parent
Definition | The parent device.
Short | The parent device
Control | 0..1
Type | Reference(Device)
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)