The characteristics, operational status and capabilities of a medical-related component of a medical device.

For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.

Additional information to describe the device.

Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

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.

The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.

The organization that assigns the identifier algorithm.

The jurisdiction to which the deviceIdentifier applies.

The organization that assigns the identifier algorithm.

Begin and end dates for the commercial distribution of the device.

National state or territory to which the marketDistribution recers, typically where the device is commercialized.

The part number or catalog number of the device.

Alphanumeric Maximum 20.

A name of the manufacturer. manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.

A The name given to or names of the device to identify it. as given by the manufacturer.

The A human-friendly name of that is used to refer to the device. device - depending on the type, it can be the brand name, the common name or alias, or other.

The type of deviceName. UDILabelName RegisteredName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. PatientReportedName.

The model number for the device. device for example as defined by the manufacturer or labeler, or other agency.

What kind of device or device system this is.

In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.

A classification or risk class of the device model.

Further information qualifying this classification of the device model.

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

The standard A device that is used part (for example a component) of the present device.

Reference to operate and communicate. the device that is part of the current device.

Number of instances of the component device in the current device.

The version Information about the packaging of the standard that device, i.e. how the device is used to operate and communicate. packaged.

The business identifier of the packaged medication.

A code that defines the specific type of packaging.

The available versions number of items contained in the device, e.g., software versions. package (devices or sub-packages).

An organization that distributes the packaged device.

Distributor's human-readable name.

Safety characteristics of the device. Distributor as an Organization resource.

Unique Device safety Identifier (UDI) Barcode string on the packaging.

Identifier to be associated with every instance for issuer and jurisdiction.

Shelf Life and storage information. The organization that assigns the identifier algorithm.

Dimensions, color etc. The jurisdiction to which the deviceIdentifier applies.

Language code The organization that assigns the identifier algorithm.

Begin and end dates for the human-readable text strings produced by commercial distribution of the device.

National state or territory to which the marketDistribution refers, typically where the device (all supported). is commercialized.

Allows packages within packages.

Device capabilities. The version of the device or software.

Type The type of capability. the device version, e.g. manufacturer, approved, internal.

Description The hardware or software module of capability. the device to which the version applies.

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

The version text.

Safety characteristics of the device.

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. Shelf Life and storage information.

Code that specifies Language code for the property DeviceDefinitionPropetyCode (Extensible). human-readable text strings produced by the device (all supported).

Property value as The potential, valid configuration settings of a quantity. device, e.g., regulation status, time properties.

Code that specifies the property.

Property value as a code, e.g., NTP4 (synced to NTP). - the data type depends on the property type.

The usage of CodeableConcept is for concepts that are normally coded but for which a code is not available - for example a device implant size that is not standardized. The property string is for text characteristics, e.g. long descriptions, warnings, etc.

An organization that is responsible for the provision and ongoing maintenance of the device.

Contact details for an organization or a particular human that is responsible for the device.

used for troubleshooting etc.

A network address on which the An associated device, attached to, used with, communicating with or linking a previous or new device may be contacted directly. model to the focal device.

If The type indicates the device is running a FHIR server, relationship of the network address should be related device to the Base URL from which a conformance statement may be retrieved. device instance.

Access A reference to on-line information about the linked device.

Descriptive information, usage information or implantation information that is not captured in an existing element.

The quantity parent device it can be part of.

A substance used to create the material(s) of which the device present in is made.

A substance that the packaging (e.g. device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the number composition of devices present in the device, only the clinically relevant materials.

Indicates an alternative material of the device.

Whether the substance is a pack, known or suspected allergen.

Indicates the number of devices production identifier(s) that are expected to appear in the same package UDI carrier on the device label.

Information aimed at providing directions for the usage of this model of device.

The circumstances that form the medicinal product). setting for using the device.

Detailed written and visual directions for the user on how to use the device.

The parent A source of information or reference for this guideline.

A clinical condition for which the device it can was designed to be part of. used.

A substance specific situation when a device should not be used because it may cause harm.

Specific hazard alert information that a user needs to create know before using the material(s) device.

A description of the general purpose or medical use of which the device is made. or its function.

The substance. Tracking of latest field safety corrective action.

Whether the last corrective action known for this device was a recall.

When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.

Indicates an alternative material The scope of the device. corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.

Whether Start and end dates of the substance is a known corrective action.

Billing code or suspected allergen. reference associated with the device.

The code or reference for the charge item.

Coefficient applicable to the billing code.

A specific time period in which this charge item applies.

The context to which this charge item applies.