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. 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. If the element is present, it must have either a @value, an @id, or extensions Unique instance identifiers assigned to a device by manufacturers other organizations or owners. The reference to the definition for the device. Unique Device Identifier (UDI) placed on a device label or package. Note that the Device may include multiple UDIs if it is sold in multiple jurisdictions. The Device record status. This is not the status of the device like availability. The availability of the device. A production identifier of the donor, donation, or pooling event associated with the biological material incorporated into the device. A name of the manufacturer or entity legally responsible for the device. The date and time when the device was manufactured. The date and time beyond which this device is no longer valid or should not be used (if applicable). Lot number assigned by the manufacturer. The serial number assigned by the organization when the device was manufactured. 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. The manufacturer's model number for the device. The part number or catalog number of the device. Devices may be associated with one or more categories. The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device. The actual design of the device or software version running on the device. Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards. Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes. Material added to a container device (typically used in specimen collection or initial processing). The material may be added by the device manufacturer or by a different party subsequent to manufacturing. Contact details for an organization or a particular human that is responsible for the device. The place where the device can be found. Descriptive information, usage information or implantation information that is not captured in an existing element. Provides additional safety characteristics about a medical device. For example devices containing latex. The higher level or encompassing device that this device is a logical part 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. The device identifier (UDI-DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The UDI-DI portion is placed on a device label or package. Note that the DeviceDefinition may include multiple UDI-DIs if it is sold in multiple jurisdictions. Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to create the device identifier. Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include: 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di. 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/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi. The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation as printed on the packaging of the device - e.g., a barcode , 2D Matrix, or RFID. Some AIDC representations contain non-printable characters and cannot be represented in a string format. For this reason, AIDC format SHALL be base64Binary encoded. The full UDI carrier as the human readable form (HRF) representation as printed on the packaging of the device. A coded entry to indicate how the data was entered. 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. The actual name that identifies the device. Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName. Indicates the default or preferred name to be displayed. 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. The type of the device version, e.g. manufacturer, approved, internal. The hardware or software module of the device to which the version applies. The date the version was installed on the device. The version text. 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. Describes the type of the standard, specification, or formal guidance. Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres. Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label. 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. Code that specifies the property, such as resolution, color, size, being represented. The value of the property specified by the associated property.type code. 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. The type of the substance added to the container. This is represented as a concept from a code system or described in a Substance resource. The quantity of the additive substance in the container; may be volume, dimensions, or other appropriate measurements, depending on the container and additive substance type. Active Inactive Entered in Error Unknown If the element is present, it must have either a @value, an @id, or extensions Barcode RFID Manual Card Self Reported Electronic Transmission Unknown If the element is present, it must have either a @value, an @id, or extensions