8.15 Resource Device - Content

8.15.1 Scope and Usage

This is a base resource that tracks individual instances of a device and their location. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, which device was implanted in or explanted from a patient, dispensing a device to a patient for their use, managing inventory, or when requesting a specific device for a patient's use. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Medical devices may also include some types of software.

Non-medical devices may include items such as a machine, cellphone, computer, software application or algorithm, etc. In short, a Device can range from a tongue depressor to an MRI. The fields in the Device resource must be flexible enough to cover this range.

The resource may be used to document the Unique Device Identifier (UDI) and information about a device where appropriate or necessary according to local jurisdictions over time. Additional information about UDI is provided in the Unique Device Identifier (UDI) section.

Devices may be categorized and may be associated with one or more categories. Device category examples include, but are not limited to: active, communicating, durable medical equipment, home use, implantable, InVitro diagnostics, personal health, point-of-care, single use, re-usable, and software.

8.15.1.0.1 Active device

'Active device' means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device. MDR (EU) 2017/745

Active Implantable Medical Devices include the definition for both active devices and implantable devices (see below). Examples include: Implantable cardiac pacemakers; Implantable defibrillator; Implantable neurostimulator systems; Leads, electrodes, adaptors for implantable pulse generators; Brachytherapy systems; Ventricular Assist Devices (VADs); Cochlear implants; Implantable infusion pumps; Implantable glucose monitors; Micro Electro-Mechanical Systems (MEMS); and their accessories where applicable.

8.15.1.0.2 Communicating device

This category of devices communicates electronically to peer information systems or possibly another device. In addition to patient observations for use by clinicians in providing care and for building a health record, the device communicates metadata about its own state and the protocol used to transfer that information.

To support the use and evaluate the reliability of the patient data, it is important to to collect and record data about the identity and operational status of the device that generated the observations. The Device resource is an important locus for such information. The information it generates for clinical and other purposes goes into other resources such as the Observation or Medication resource depending upon what the device does. To support device-related information about Communicating Medical Devices the Device resource needs to have elements that describe not only the basic information like the serial number, manufacturer name and model number, but information about the protocol, its version, its certification, the properties it has to perform its purposed tasks such as internal clocks, synchronization state, resolution, etc.

8.15.1.0.3 Durable Medical Equipment

Equipment and supplies that provides therapeutic benefits to a patient in need because of certain medical conditions and/or illnesses, and which are ordered by a health care provider for everyday or extended use.

Examples include: oxygen equipment, suction pumps, traction equipment, home infusion services, continuous positive airway pressure (CPAP) devices, hospital beds, wheelchairs, crutches walkers, canes, or blood testing strips and meters for diabetics.

8.15.1.0.4 Home Use device

A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes.

• A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
• A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

US Food and Drug Administration Center for Devices and Radiological Health. Home Use Devices. Accessed 12 May 2022

8.15.1.0.5 Implantable device

Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device is regarded as an implant for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise to protect human health. 21CFR Part 860.3 Accessed 12 May 2022

'implantable device' means any device, including those that are partially or wholly absorbed, which is intended:

• to be totally introduced into the human body, or
• to replace an epithelial surface or the surface of the eye,

by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device; MDR (EU) 2017/745 Accessed 12 May 2022

8.15.1.0.6 InVitro Medical device

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person 's overall health to help cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person 's DNA to detect genomic variations.

Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. US Food and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics Accessed 12 May 2022

8.15.1.0.7 Patient-use device

Patient-use, or home use devices, intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes US Food and Drug Administration Center for Devices and Radiological Health. Home Use Devices. Accessed 13 March 2020. PHDs are the subset of patient-use devices that report their information to a peer via a protocol.

8.15.1.0.8 Personal Health device

One class of communicating devices is the Personal Health Device or PHD. PHDs are medical devices that can be used by patients or others who are typically not medical professions, to gather patient observations and information. These devices can often be purchased in department stores or online by anyone. They may be regulated as medical devices, or not.

PHDs include the popular fitness trackers often combined with heart rate monitors, but also blood pressure monitors, weight scales, pulse oximeters, thermometers, and, for those that require them, glucose meters. Over time more sophisticated devices such as continuous glucose monitors, insulin pumps, vital signs monitors including ECGs, and even spirometers are entering the PHD consumer market. These devices communicate measurement data and data about themselves via a digital transport protocol to some peer entity, often a mobile phone or tablet. The protocol may follow a standard but most protocols are proprietary. In either case, it is common practice for manufacturers to provide free applications that run on these mobile platforms for the purpose of communicating with their devices.

The fields populated in the Device resource by PHDs, typically via a gateway, is the information a PHD reports about itself electronically. There is no input by the patient except for information the patient may enter on the device through some UI. This device reporting capability distinguishes communicating PHDs from the general set of patient-use devices.

8.15.1.0.9 Point-of-Care device

PoCDs are of another level of complexity compared to PHDs: they include devices like multi-parameter physiological patient monitors, anesthesia workstations, infusion pumps and numerous other kinds of devices that provide near-real-time information about patient condition or therapy, potentially including dozens or hundreds of variables coming from a single device system. They may be structurally complex, involving multiple subsystems that are themselves complex, such as a ventilator or gas analyzer functioning within an anesthesia workstation, or pluggable modules in a patient monitor controlling invasive blood pressure or gathering EEG data.

Information systems using such data need to be able to understand the structure and dynamic state of the devices originating them, generally requiring access to what is in effect a dynamically changing model of the device and its subsystems and measuring capabilities. This requires more than a single Device resource - a hierarchy of Device resources is constructed carrying data about the top-level containing device (for example a monitor), and a hierarchy of contained Device resources representing subsystems (in the monitor, builtin and attached modular measurement capabilities), channels, and DeviceMetric resources representing individual measurements or computations.

8.15.1.0.10 Single-Use device

A device that is intended to be used on one individual during a single procedure; MDR (EU) 2017/745 Accessed 12 May 2022

8.15.1.0.11 Reusable device

Reusable medical devices are devices that health care providers can reuse to diagnose and treat one or multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and laryngoscopes. US Food and Drug Administration Center for Devices and Radiological Health Reusable Medical Devices

8.15.1.0.12 Software

The Device resource is intended to represent an instance of a software component or application. A software item like a data transformer or converter, or a clinical support algorithm, may be an independently deployed, managed and configured entity that contributes to patient care and needs to be documented just a surely as, say, a physical cardiac monitor. The FHIR Device resource can contain instance data such as version information and operational attributes. It can also represent the relationship of the software item to other device and information system components through reference linkages. This category includes software regardless of whether or not is regulated. Device resource instances documenting software items are important to traceability of data and analyzing adverse events, and so have important patient safety roles.

8.15.1.0.13 Device and DeviceDefinition

When referring to a specific instance, even without specific instance details, Device is to be used, not a DeviceDefinition. The context of a data exchange indicates whether the data is representing a physical instance or a "kind", not the presence of instance data such as lot and serial numbers.

Some examples:

1. In a Procedure, reporting the use of a pump for which we have no instance data - the pump is a physical instance. Whether the lot number (for example) is known or not, depends on the circumstance - in another Procedure or in an update of the Procedure, the lot number could be added. Hence the use of Device.
2. When a device gets replaced by another device of the same type. In this case, a procedure indicates that one instance of the device is removed/explanted/discarded, and another instance is used. These are physical instances for which instance data might exist and be known, or not.

8.15.1.1 Boundaries and Relationships

Note to Implementers: The module pages under development by Orders and Observations will further describe the variations of device use cases across the device resources, e.g., Device, DeviceDefinition, DeviceAssociation, DeviceDispense, DeviceMetric, DeviceRequest, and Device Usage.

These are the device related resources

• Device (this resource)
• DeviceDefinition - Describes a "kind" of device - not a specific instance of the device. A kind of device is frequently defined and documented by the manufacturer, reseller, or regulatory. Documentation would include any information that applies to all instances of a device, and may be published through a catalog. For example, the characteristics of a test analyzer, x-ray machine, or wheelchair.
• DeviceMetric - Describes a measurement, calculation or setting capability of a device instance. A Device may include multiple device metrics, each yielding a different observation. The DeviceMetric models the properties of the Observations generated by and/or about the device such as whether or not the Observation is a setting. A DeviceMetric describes aspects of the device that may change over time. In contrast, the Device.property is used to capture inherent, essentially fixed, characteristics of the device, such as a "large" blood pressure cuff, the bore size of an MRI, the color of a lead. (Such static characteristics may also be recorded in DeviceDefinition.)
• DeviceAssociation - Records the association of a device with a subject (e.g. a Patient by ownership, or a Practitioner by usage during a procedure).
• DeviceRequest/DeviceDispense
• SupplyRequest/SupplyDelivery
• DeviceUsage
• NutritionOrder - An order for nutrition can request to a specific device to administer enteral feeding.
• Observation - A measurement can be generated by many types of devices. It may be linked to and supplemented by data about the current structure and status of the device itself in one or more Device or DeviceMetric resources.
• Procedure - A procedure can be performed using a variety of devices, or a device can be implanted or otherwise associated with a patient.
• MedicationAdministration - A medication administration can be performed using a variety of devices.

In FHIR, the Device represents either the device in total, or a component of an encapsulating device when there is a need for individual tracking of a component. A Device as a component then points to the parent device it is part of. The top-level Device captures the actual data about the instance of the device and the instances of all its children that either provides identifying characteristics of the Device (including applicable UDI – unique device identification) and data that can vary dynamically by device, e.g., specific settings at a particular point in time.

The DeviceMetric models the properties of the Observations generated by the device, such as whether or not the Observation is a setting.

Devices differ from medications because they are not "used up" - they remain active in or for a patient for a longer duration. They also may be re-used, particularly non-implanted devices and those used for diagnostics and procedures. Frequently, when a device is packaged with a medication, the ordering, dispense, and administration processes typically focus on the medication aspects and reference the device.

In the case of an infusion pump, while some actions are focused on the device (e.g., ordering to a room or maintaining the pump), the focus is as well on the medication while the device is used for administration. However, that separation is not always as clear and may be impacted by specific implementations. Regardless, the Medication resource should not be used to represent (implanted) devices, rather reference the relationship where an actual device needs to be tracked in addition to the medication. In some sense the Medication is analogous to the Observation generated by a Blood Pressure personal health device. The Observation resource contains the blood pressure values, units and the time stamp while the Device resource contains the manufacturer name, model number, serial number, firmware and hardware versions, exchange protocol information, any clock capabilities, etc.

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Structure

Name	Flags	Card.	Type	Description & Constraints
Device	TU		DomainResource	Item used in healthcare + Rule: only one Device.name.display SHALL be true when there is more than one Device.name Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier		0..*	Identifier	Instance identifier
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	Σ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier	Σ	1..1	string	Mandatory fixed portion of UDI
deviceIdentifierSystem		0..1	uri	The namespace for the device identifier value
issuer	Σ	1..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	Σ	0..1	string	UDI Human Readable Barcode String
entryType		0..1	code	barcode | rfid | manual | card | self-reported | electronic-transmission | unknown Binding: UDI Entry Type (Required)
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: FHIR Device Status (Required)
availabilityStatus		0..1	CodeableConcept	lost | damaged | destroyed | available Binding: FHIR Device Availability Status (Extensible)
biologicalSourceEvent		0..1	Identifier	An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
manufacturer		0..1	string	Name of device manufacturer
manufactureDate		0..1	dateTime	Date when the device was made
expirationDate		0..1	dateTime	Date and time of expiry of this device (if applicable)
lotNumber		0..1	string	Lot number of manufacture
serialNumber		0..1	string	Serial number assigned by the manufacturer
name	C	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient
value	Σ	1..1	string	The term that names the device
type	Σ	1..1	CodeableConcept	registered-name | user-friendly-name | patient-reported-name Binding: Device Name Type (Extensible)
display	?!ΣC	0..1	boolean	The preferred device name
modelNumber		0..1	string	The manufacturer's model number for the device
partNumber		0..1	string	The part number or catalog number of the device
category		0..*	CodeableConcept	Indicates a high-level grouping of the device Binding: FHIR Device Category (Example)
type		0..*	CodeableConcept	The kind or type of device Binding: Device Type (Example)
deviceVersion		0..*	BackboneElement	The actual design of the device or software version running on the device
type		0..1	CodeableConcept	The type of the device version, e.g. manufacturer, approved, internal Binding: Device Version Type (Example)
component		0..1	Identifier	The hardware or software module of the device to which the version applies
installDate		0..1	dateTime	The date the version was installed on the device
value		1..1	string	The version text
conformsTo		0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
category		0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement Binding: Device Specification Category (Example)
specification		1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to Binding: Device Specification Type (Example)
version		0..1	string	Specific form or variant of the standard
property		0..*	BackboneElement	Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: Device Property Type (Example)
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
mode		0..1	CodeableConcept	The designated condition for performing a task Binding: FHIR Device Operation Mode (Example)
cycle		0..1	Count	The series of occurrences that repeats during the operation of the device
duration		0..1	Duration	A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
endpoint		0..*	Reference(Endpoint)	Technical endpoints providing access to electronic services provided by the device
gateway		0..*	CodeableReference(Device)	Linked device acting as a communication/data collector, translator or controller
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device Binding: Device Safety (Example)
parent		0..1	Reference(Device)	The higher level or encompassing device that this device is a logical part of
Documentation for this format

See the Extensions for this resource

<Device xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <definition><!-- 0..1 Reference(DeviceDefinition) The reference to the definition for the device --></definition>
 <udiCarrier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI -->
  <deviceIdentifierSystem value="[uri]"/><!-- 0..1 The namespace for the device identifier value -->
  <issuer value="[uri]"/><!-- 1..1 UDI Issuing Organization -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown -->
 </udiCarrier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error -->
 <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus>
 <biologicalSourceEvent><!-- 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled --></biologicalSourceEvent>
 <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) -->
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->
 <name>  <!-- I 0..* The name or names of the device as known to the manufacturer and/or patient -->
  <value value="[string]"/><!-- 1..1 The term that names the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
  <display value="[boolean]"/><!-- I 0..1 The preferred device name -->
 </name>
 <modelNumber value="[string]"/><!-- 0..1 The manufacturer's model number for the device -->
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <category><!-- 0..* CodeableConcept Indicates a high-level grouping of the device --></category>
 <type><!-- 0..* CodeableConcept The kind or type of device --></type>
 <deviceVersion>  <!-- 0..* The actual design of the device or software version running on the device -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <installDate value="[dateTime]"/><!-- 0..1 The date the version was installed on the device -->
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance.  communication | performance | measurement --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to --></specification>
  <version value="[string]"/><!-- 0..1 Specific form or variant of the standard -->
 </conformsTo>
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of the device.  e.g., time properties, size, material, etc. -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <mode><!-- 0..1 CodeableConcept The designated condition for performing a task --></mode>
 <cycle><!-- 0..1 Count The series of occurrences that repeats during the operation of the device --></cycle>
 <duration><!-- 0..1 Duration A measurement of time during the device's operation (e.g., days, hours, mins, etc.) --></duration>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <location><!-- 0..1 Reference(Location) Where the device is found --></location>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <endpoint><!-- 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device --></endpoint>
 <gateway><!-- 0..* CodeableReference(Device) Linked device acting as a communication/data collector, translator or controller --></gateway>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of --></parent>
</Device>

{
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "definition" : { Reference(DeviceDefinition) }, // The reference to the definition for the device
  "udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  Mandatory fixed portion of UDI
    "deviceIdentifierSystem" : "<uri>", // The namespace for the device identifier value
    "issuer" : "<uri>", // R!  UDI Issuing Organization
    "jurisdiction" : "<uri>", // Regional UDI authority
    "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
    "carrierHRF" : "<string>", // UDI Human Readable Barcode String
    "entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
  }],
  "status" : "<code>", // active | inactive | entered-in-error
  "availabilityStatus" : { CodeableConcept }, // lost | damaged | destroyed | available
  "biologicalSourceEvent" : { Identifier }, // An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  "manufacturer" : "<string>", // Name of device manufacturer
  "manufactureDate" : "<dateTime>", // Date when the device was made
  "expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
  "lotNumber" : "<string>", // Lot number of manufacture
  "serialNumber" : "<string>", // Serial number assigned by the manufacturer
  "name" : [{ // I The name or names of the device as known to the manufacturer and/or patient
    "value" : "<string>", // R!  The term that names the device
    "type" : { CodeableConcept }, // R!  registered-name | user-friendly-name | patient-reported-name
    "display" : <boolean> // I The preferred device name
  }],
  "modelNumber" : "<string>", // The manufacturer's model number for the device
  "partNumber" : "<string>", // The part number or catalog number of the device
  "category" : [{ CodeableConcept }], // Indicates a high-level grouping of the device
  "type" : [{ CodeableConcept }], // The kind or type of device
  "deviceVersion" : [{ // The actual design of the device or software version running on the device
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "installDate" : "<dateTime>", // The date the version was installed on the device
    "value" : "<string>" // R!  The version text
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance.  communication | performance | measurement
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to
    "version" : "<string>" // Specific form or variant of the standard
  }],
  "property" : [{ // Inherent, essentially fixed, characteristics of the device.  e.g., time properties, size, material, etc.
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "mode" : { CodeableConcept }, // The designated condition for performing a task
  "cycle" : { Count }, // The series of occurrences that repeats during the operation of the device
  "duration" : { Duration }, // A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "location" : { Reference(Location) }, // Where the device is found
  "url" : "<uri>", // Network address to contact device
  "endpoint" : [{ Reference(Endpoint) }], // Technical endpoints providing access to electronic services provided by the device
  "gateway" : [{ CodeableReference(Device) }], // Linked device acting as a communication/data collector, translator or controller
  "note" : [{ Annotation }], // Device notes and comments
  "safety" : [{ CodeableConcept }], // Safety Characteristics of Device
  "parent" : { Reference(Device) } // The higher level or encompassing device that this device is a logical part of
}

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:Device;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:definition [ Reference(DeviceDefinition) ] ; # 0..1 The reference to the definition for the device
  fhir:udiCarrier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 Mandatory fixed portion of UDI
    fhir:deviceIdentifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value
    fhir:issuer [ uri ] ; # 1..1 UDI Issuing Organization
    fhir:jurisdiction [ uri ] ; # 0..1 Regional UDI authority
    fhir:carrierAIDC [ base64Binary ] ; # 0..1 UDI Machine Readable Barcode String
    fhir:carrierHRF [ string ] ; # 0..1 UDI Human Readable Barcode String
    fhir:entryType [ code ] ; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
  ] ... ) ;
  fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error
  fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | available
  fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  fhir:manufacturer [ string ] ; # 0..1 Name of device manufacturer
  fhir:manufactureDate [ dateTime ] ; # 0..1 Date when the device was made
  fhir:expirationDate [ dateTime ] ; # 0..1 Date and time of expiry of this device (if applicable)
  fhir:lotNumber [ string ] ; # 0..1 Lot number of manufacture
  fhir:serialNumber [ string ] ; # 0..1 Serial number assigned by the manufacturer
  fhir:name ( [ # 0..* I The name or names of the device as known to the manufacturer and/or patient
    fhir:value [ string ] ; # 1..1 The term that names the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
    fhir:display [ boolean ] ; # 0..1 I The preferred device name
  ] ... ) ;
  fhir:modelNumber [ string ] ; # 0..1 The manufacturer's model number for the device
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* Indicates a high-level grouping of the device
  fhir:type  ( [ CodeableConcept ] ... ) ; # 0..* The kind or type of device
  fhir:deviceVersion ( [ # 0..* The actual design of the device or software version running on the device
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:installDate [ dateTime ] ; # 0..1 The date the version was installed on the device
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance.  communication | performance | measurement
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to
    fhir:version [ string ] ; # 0..1 Specific form or variant of the standard
  ] ... ) ;
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of the device.  e.g., time properties, size, material, etc.
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:mode [ CodeableConcept ] ; # 0..1 The designated condition for performing a task
  fhir:cycle [ Count ] ; # 0..1 The series of occurrences that repeats during the operation of the device
  fhir:duration [ Duration ] ; # 0..1 A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
  fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device
  fhir:contact  ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support
  fhir:location [ Reference(Location) ] ; # 0..1 Where the device is found
  fhir:url [ uri ] ; # 0..1 Network address to contact device
  fhir:endpoint  ( [ Reference(Endpoint) ] ... ) ; # 0..* Technical endpoints providing access to electronic services provided by the device
  fhir:gateway  ( [ CodeableReference(Device) ] ... ) ; # 0..* Linked device acting as a communication/data collector, translator or controller
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety Characteristics of Device
  fhir:parent [ Reference(Device) ] ; # 0..1 The higher level or encompassing device that this device is a logical part of
]

Structure

Name	Flags	Card.	Type	Description & Constraints
Device	TU		DomainResource	Item used in healthcare + Rule: only one Device.name.display SHALL be true when there is more than one Device.name Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier		0..*	Identifier	Instance identifier
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	Σ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier	Σ	1..1	string	Mandatory fixed portion of UDI
deviceIdentifierSystem		0..1	uri	The namespace for the device identifier value
issuer	Σ	1..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	Σ	0..1	string	UDI Human Readable Barcode String
entryType		0..1	code	barcode | rfid | manual | card | self-reported | electronic-transmission | unknown Binding: UDI Entry Type (Required)
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: FHIR Device Status (Required)
availabilityStatus		0..1	CodeableConcept	lost | damaged | destroyed | available Binding: FHIR Device Availability Status (Extensible)
biologicalSourceEvent		0..1	Identifier	An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
manufacturer		0..1	string	Name of device manufacturer
manufactureDate		0..1	dateTime	Date when the device was made
expirationDate		0..1	dateTime	Date and time of expiry of this device (if applicable)
lotNumber		0..1	string	Lot number of manufacture
serialNumber		0..1	string	Serial number assigned by the manufacturer
name	C	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient
value	Σ	1..1	string	The term that names the device
type	Σ	1..1	CodeableConcept	registered-name | user-friendly-name | patient-reported-name Binding: Device Name Type (Extensible)
display	?!ΣC	0..1	boolean	The preferred device name
modelNumber		0..1	string	The manufacturer's model number for the device
partNumber		0..1	string	The part number or catalog number of the device
category		0..*	CodeableConcept	Indicates a high-level grouping of the device Binding: FHIR Device Category (Example)
type		0..*	CodeableConcept	The kind or type of device Binding: Device Type (Example)
deviceVersion		0..*	BackboneElement	The actual design of the device or software version running on the device
type		0..1	CodeableConcept	The type of the device version, e.g. manufacturer, approved, internal Binding: Device Version Type (Example)
component		0..1	Identifier	The hardware or software module of the device to which the version applies
installDate		0..1	dateTime	The date the version was installed on the device
value		1..1	string	The version text
conformsTo		0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
category		0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement Binding: Device Specification Category (Example)
specification		1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to Binding: Device Specification Type (Example)
version		0..1	string	Specific form or variant of the standard
property		0..*	BackboneElement	Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: Device Property Type (Example)
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
mode		0..1	CodeableConcept	The designated condition for performing a task Binding: FHIR Device Operation Mode (Example)
cycle		0..1	Count	The series of occurrences that repeats during the operation of the device
duration		0..1	Duration	A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
endpoint		0..*	Reference(Endpoint)	Technical endpoints providing access to electronic services provided by the device
gateway		0..*	CodeableReference(Device)	Linked device acting as a communication/data collector, translator or controller
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device Binding: Device Safety (Example)
parent		0..1	Reference(Device)	The higher level or encompassing device that this device is a logical part of
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<Device xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <definition><!-- 0..1 Reference(DeviceDefinition) The reference to the definition for the device --></definition>
 <udiCarrier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI -->
  <deviceIdentifierSystem value="[uri]"/><!-- 0..1 The namespace for the device identifier value -->
  <issuer value="[uri]"/><!-- 1..1 UDI Issuing Organization -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown -->
 </udiCarrier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error -->
 <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus>
 <biologicalSourceEvent><!-- 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled --></biologicalSourceEvent>
 <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) -->
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->
 <name>  <!-- I 0..* The name or names of the device as known to the manufacturer and/or patient -->
  <value value="[string]"/><!-- 1..1 The term that names the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
  <display value="[boolean]"/><!-- I 0..1 The preferred device name -->
 </name>
 <modelNumber value="[string]"/><!-- 0..1 The manufacturer's model number for the device -->
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <category><!-- 0..* CodeableConcept Indicates a high-level grouping of the device --></category>
 <type><!-- 0..* CodeableConcept The kind or type of device --></type>
 <deviceVersion>  <!-- 0..* The actual design of the device or software version running on the device -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <installDate value="[dateTime]"/><!-- 0..1 The date the version was installed on the device -->
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance.  communication | performance | measurement --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to --></specification>
  <version value="[string]"/><!-- 0..1 Specific form or variant of the standard -->
 </conformsTo>
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of the device.  e.g., time properties, size, material, etc. -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <mode><!-- 0..1 CodeableConcept The designated condition for performing a task --></mode>
 <cycle><!-- 0..1 Count The series of occurrences that repeats during the operation of the device --></cycle>
 <duration><!-- 0..1 Duration A measurement of time during the device's operation (e.g., days, hours, mins, etc.) --></duration>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <location><!-- 0..1 Reference(Location) Where the device is found --></location>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <endpoint><!-- 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device --></endpoint>
 <gateway><!-- 0..* CodeableReference(Device) Linked device acting as a communication/data collector, translator or controller --></gateway>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of --></parent>
</Device>

JSON Template

{
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "definition" : { Reference(DeviceDefinition) }, // The reference to the definition for the device
  "udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  Mandatory fixed portion of UDI
    "deviceIdentifierSystem" : "<uri>", // The namespace for the device identifier value
    "issuer" : "<uri>", // R!  UDI Issuing Organization
    "jurisdiction" : "<uri>", // Regional UDI authority
    "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
    "carrierHRF" : "<string>", // UDI Human Readable Barcode String
    "entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
  }],
  "status" : "<code>", // active | inactive | entered-in-error
  "availabilityStatus" : { CodeableConcept }, // lost | damaged | destroyed | available
  "biologicalSourceEvent" : { Identifier }, // An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  "manufacturer" : "<string>", // Name of device manufacturer
  "manufactureDate" : "<dateTime>", // Date when the device was made
  "expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
  "lotNumber" : "<string>", // Lot number of manufacture
  "serialNumber" : "<string>", // Serial number assigned by the manufacturer
  "name" : [{ // I The name or names of the device as known to the manufacturer and/or patient
    "value" : "<string>", // R!  The term that names the device
    "type" : { CodeableConcept }, // R!  registered-name | user-friendly-name | patient-reported-name
    "display" : <boolean> // I The preferred device name
  }],
  "modelNumber" : "<string>", // The manufacturer's model number for the device
  "partNumber" : "<string>", // The part number or catalog number of the device
  "category" : [{ CodeableConcept }], // Indicates a high-level grouping of the device
  "type" : [{ CodeableConcept }], // The kind or type of device
  "deviceVersion" : [{ // The actual design of the device or software version running on the device
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "installDate" : "<dateTime>", // The date the version was installed on the device
    "value" : "<string>" // R!  The version text
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance.  communication | performance | measurement
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to
    "version" : "<string>" // Specific form or variant of the standard
  }],
  "property" : [{ // Inherent, essentially fixed, characteristics of the device.  e.g., time properties, size, material, etc.
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "mode" : { CodeableConcept }, // The designated condition for performing a task
  "cycle" : { Count }, // The series of occurrences that repeats during the operation of the device
  "duration" : { Duration }, // A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "location" : { Reference(Location) }, // Where the device is found
  "url" : "<uri>", // Network address to contact device
  "endpoint" : [{ Reference(Endpoint) }], // Technical endpoints providing access to electronic services provided by the device
  "gateway" : [{ CodeableReference(Device) }], // Linked device acting as a communication/data collector, translator or controller
  "note" : [{ Annotation }], // Device notes and comments
  "safety" : [{ CodeableConcept }], // Safety Characteristics of Device
  "parent" : { Reference(Device) } // The higher level or encompassing device that this device is a logical part of
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:Device;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:definition [ Reference(DeviceDefinition) ] ; # 0..1 The reference to the definition for the device
  fhir:udiCarrier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 Mandatory fixed portion of UDI
    fhir:deviceIdentifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value
    fhir:issuer [ uri ] ; # 1..1 UDI Issuing Organization
    fhir:jurisdiction [ uri ] ; # 0..1 Regional UDI authority
    fhir:carrierAIDC [ base64Binary ] ; # 0..1 UDI Machine Readable Barcode String
    fhir:carrierHRF [ string ] ; # 0..1 UDI Human Readable Barcode String
    fhir:entryType [ code ] ; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
  ] ... ) ;
  fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error
  fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | available
  fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  fhir:manufacturer [ string ] ; # 0..1 Name of device manufacturer
  fhir:manufactureDate [ dateTime ] ; # 0..1 Date when the device was made
  fhir:expirationDate [ dateTime ] ; # 0..1 Date and time of expiry of this device (if applicable)
  fhir:lotNumber [ string ] ; # 0..1 Lot number of manufacture
  fhir:serialNumber [ string ] ; # 0..1 Serial number assigned by the manufacturer
  fhir:name ( [ # 0..* I The name or names of the device as known to the manufacturer and/or patient
    fhir:value [ string ] ; # 1..1 The term that names the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
    fhir:display [ boolean ] ; # 0..1 I The preferred device name
  ] ... ) ;
  fhir:modelNumber [ string ] ; # 0..1 The manufacturer's model number for the device
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* Indicates a high-level grouping of the device
  fhir:type  ( [ CodeableConcept ] ... ) ; # 0..* The kind or type of device
  fhir:deviceVersion ( [ # 0..* The actual design of the device or software version running on the device
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:installDate [ dateTime ] ; # 0..1 The date the version was installed on the device
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance.  communication | performance | measurement
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to
    fhir:version [ string ] ; # 0..1 Specific form or variant of the standard
  ] ... ) ;
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of the device.  e.g., time properties, size, material, etc.
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:mode [ CodeableConcept ] ; # 0..1 The designated condition for performing a task
  fhir:cycle [ Count ] ; # 0..1 The series of occurrences that repeats during the operation of the device
  fhir:duration [ Duration ] ; # 0..1 A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
  fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device
  fhir:contact  ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support
  fhir:location [ Reference(Location) ] ; # 0..1 Where the device is found
  fhir:url [ uri ] ; # 0..1 Network address to contact device
  fhir:endpoint  ( [ Reference(Endpoint) ] ... ) ; # 0..* Technical endpoints providing access to electronic services provided by the device
  fhir:gateway  ( [ CodeableReference(Device) ] ... ) ; # 0..* Linked device acting as a communication/data collector, translator or controller
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety Characteristics of Device
  fhir:parent [ Reference(Device) ] ; # 0..1 The higher level or encompassing device that this device is a logical part of
]

Changes from both R4 and R4B

Device
Device.udiCarrier.deviceIdentifier	Min Cardinality changed from 0 to 1
Device.udiCarrier.deviceIdentifierSystem	Added Element
Device.udiCarrier.issuer	Min Cardinality changed from 0 to 1
Device.udiCarrier.entryType	Add code electronic-transmission
Device.status	Remove code unknown
Device.availabilityStatus	Added Element
Device.biologicalSourceEvent	Added Element
Device.name	Renamed from deviceName to name
Device.name.value	Added Mandatory Element
Device.name.type	Moved from Device.deviceName to Device.name Type changed from code to CodeableConcept Change binding strength from required to extensible
Device.name.display	Added Element
Device.category	Added Element
Device.type	Max Cardinality changed from 1 to *
Device.deviceVersion	Added Element
Device.deviceVersion.type	Added Element
Device.deviceVersion.component	Added Element
Device.deviceVersion.installDate	Added Element
Device.deviceVersion.value	Added Mandatory Element
Device.conformsTo	Renamed from specialization to conformsTo
Device.conformsTo.category	Added Element
Device.conformsTo.specification	Added Mandatory Element
Device.conformsTo.version	Moved from Device.specialization to Device.conformsTo
Device.property.value[x]	Added Mandatory Element
Device.mode	Added Element
Device.cycle	Added Element
Device.duration	Added Element
Device.endpoint	Added Element
Device.gateway	Added Element
Device.statusReason	Deleted (-> reason was removed. DeviceAssociation can be used)
Device.distinctIdentifier	Deleted
Device.deviceName.name	Deleted
Device.specialization.systemType	Deleted
Device.version	Deleted
Device.property.valueQuantity	Deleted
Device.property.valueCode	Deleted
Device.patient	Deleted (-> patient association is in DeviceAssociation)

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.