The Device segment identifies an instance or 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. 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. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.
| Seq# | DataElement | Description | Must Implement | Flags | Cardinality | Length | C.LEN | Vocabulary | DataType |
|---|---|---|---|---|---|---|---|---|---|
DEV
|
|||||||||
1
|
00816 | Action Code | SHALL | [1..1] | [2..2] | ID | |||
2
|
02457 | Unique Device Identifier |
MAY
True:
False:
|
C |
[1..1] [0..1] |
EI | |||
|
3
|
03483 | Device Type |
MAY
True:
False:
|
C |
[1..1] [0..1] |
CNE | |||
|
4
|
02501 | Device Status | [0..*] | CNE | |||||
|
5
|
01247 | Manufacturer/Distributor | [0..1] | XON | |||||
|
6
|
01249 | Brand Name | = | [0..1] | 60 | ST | |||
|
7
|
01252 | Model Identifier | = | [0..1] | 60 | ST | |||
|
8
|
01253 | Catalogue Identifier | = | [0..1] | 60 | ST | |||
|
9
|
03476 | UDI Device Identifier | [0..1] | EI | |||||
|
10
|
03479 | Device Lot Number | [0..1] | ST | |||||
|
11
|
03480 | Device Serial Number | [0..1] | ST | |||||
|
12
|
03477 | Device Manufacture Date | [0..1] | DTM | |||||
|
13
|
03478 | Device Expiry Date | [0..1] | DTM | |||||
|
14
|
02465 | Safety Characteristics | [0..*] | CWE | |||||
|
15
|
03481 | Device Donation Identification | [0..1] | EI | |||||
|
16
|
02502 | Software Version Number | [0..1] | ST | |||||
|
17
|
02459 | Implantation Status | [0..1] | CNE | |||||
(Definition from OH1.2 in Ch. 3)
Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from OH2.2 in Ch. 3)
Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from OH3.2 in Ch. 3)
Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from OH4.2 in Ch. 3)
Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from ORC.35 in Ch. 4)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when either ORC-2 and/or ORC 3 is valued with a unique identifier in accordance with Chapter 2, Section 2.10.4.2.
(Definition from OBR.55 in Ch. 4)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when either an OBR-2 and/or OBR-3 is valued with unique identifier in accordance with Chapter 2, Section 2.10.4.2.
(Definition from IPC.10 in Ch. 4)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when the combination of IPC-1, IPC-2, IPC-3, and IPC-4 represents a unique identifier according to Chapter 2, Section 2.10.4.2.
(Definition from BPX.22 in Ch. 4)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when an BPX is uniquely identified sufficiently within the specific implementation using BPX-17 or BPX-6 as agreed to by the trading partners and in accordance with Chapter 2, Section 2.10.4.2.
(Definition from BTX.21 in Ch. 4)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when an BTX is uniquely identified sufficiently within the specific implementation using BTX-20 or BTX-3 as agreed to by the trading partners in accordance with Chapter 2, Section 2.10.4.2.
(Definition from DON.34 in Ch. 4)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when an DON is uniquely identified sufficiently within the specific implementation using DON-1 in accordance with Chapter 2, Section 2.10.4.2.
(Definition from BUI.13 in Ch. 4)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when an BUI is uniquely identified sufficiently within the specific implementation using BUI-2 in accordance with Chapter 2, Section 2.10.4.2
(Definition from RXV.22 in Ch. 4A)
Definition: The intended handling by the receiver of the infusion order is represented by this segment. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from CDO.2 in Ch. 4A)
Definition: The Action Code indicates whether the cumulative dosage segment is intended to be added, deleted, updated, or did not change. If the field is not valued in any CDO segments for the order, the segments are considered to have been sent in snapshot mode. If some but not all CDO segments for the order do not have the action code valued, the default value is Add. Refer to HL7 Table 0206 - Segment Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from OBR.55 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when an either OBR-2 and/or OBR-3 is valued with unique identifier in accordance with Chapter 2, Section 2.10.4.2.
(Definition from OBX.31 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when an OBX-21 is valued in accordance with guidance in Chapter 2, Section 2.10.4.2.
(Definition from SPM.35 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when an SPM-2 or SPM-31 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.
(Definition from PRT.2 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0287 – Problem/goal action code for valid values.
(Definition from CSR.17 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when CSR-1 and CSR-4, or CSR-2 and CSR-5 are valued as agreed to by the trading partners in accordance with the guidance in Chapter 2, Section 2.10.4.2.
(Definition from CTI.4 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when CTI-1 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.
(Definition from SHP.12 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when SHP-1 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.
(Definition from PAC.9 in Ch. 7)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.
The action code can only be used when PAC-2 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.
(Definition from GOL.1 in Ch. 12)
Definition: The action code field gives the intent of the problem or goal. Refer to HL7 Table 0287 – Problem/Goal Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from PRB.1 in Ch. 12)
Definition: This field contains the intent of the message. Refer to HL7 Table 0287 – Problem/Goal Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from PTH.1 in Ch. 12)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0287 – Problem/Goal Action Code in Chapter 2C, Code Tables, for valid values.
(Definition from DEV.1 in Ch. 17)
Definition: This field reveals the intent of the message. Refer to HL7 Table 0287 – Problem/goal action code for valid values.
Definition: This field contains a unique identifier for the Device represented, either an actual device, or type of device.
When this segment is used as an extension of a PRT segment in the message, e.g., additional device information obtained for an implantable device, DEV-2 must be equal to PRT-10 Participation Device. When PRT-22 Participation Device Type is used, DEV-3 must be equal to PRT-22.
Condition: Either DEV-2 Unique Device Identifier or DEV-3 Device Type must be valued, or both are valued.
(Definition from PRT.22 in Ch. 7)
Definition: This field contains the type of device used in the participation.
When communicating a UDI, the UDI may either be uniquely identifying an instance of a device, or a type of device. This can be asserted based on the inclusion or absence of a serial number in the Product Identifier section of the UDI. When the serial number is present, PRT-10 must be used, while if it is absent, PRT-22 must be used.
When communicating a UDI in this field, the coding system used is limited to FDA (FDAUDI), HIBCC (HIBUDI), ICCBBA (ICCUDI), and GS1 (GS1UDI) coding systems defined in HL7 Table 0396.
Condition: At least one of the PRT-5 Person, PRT-8 Organization, PRT-9 Location, or PRT-10 Device or PRT-22 Device Type fields must be valued.
See Externally HL7 defined HL70961 in Chapter 2C for suggested values.
(Definition from DEV.3 in Ch. 17)
Definition: This field contains the type of device used in the participation.
See Externally HL7 defined 0961 in Chapter 2C for a list of suggested values. This field can repeat.
When intended to have the additional device information for the device referenced in a PRT segment in the message, DEV-2 must be equal to PRT-10 Device. When PRT-22 Device Type is used, DEV-3 must be equal.
When communicating a UDI Carrier, the UDI may either be uniquely identifying an instance of a device, or a type of device. This can be asserted based on the inclusion or absence of a serial number in the Product Identifier section of the UDI. When the serial number is present, PRT-10 must be used, while if it is absent, PRT-22 must be used.
When communicating a UDI Carrier in this field, the coding system used is limited to FDA (FDAUDI), HIBCC (HIBUDI), ICCBBA (ICCUDI), and GS1 (GS1UDI) coding systems defined in HL7 Table 0396.
Condition: Either DEV-2 Unique Device Identifier or DEV-3 Device Type must be valued, or both are valued.
Definition: The device status indicates the availability of the device, e.g., active, inactive. Refer to Externally HL7 Defined Table 0962 for a list of valid values.
(Definition from PDC.1 in Ch. 7)
Definition: This field contains the identity of the manufacturer/distributor.
(Definition from DEV.5 in Ch. 17)
Definition: This field contains the identity of the manufacturer/distributor.
(Definition from PDC.3 in Ch. 7)
Definition: This field contains the name under which the product is marketed by this manufacturer.
(Definition from DEV.6 in Ch. 17)
Definition: This field contains the name under which the product is marketed by this manufacturer.
(Definition from PDC.6 in Ch. 7)
Definition: This field contains the manufacturer's model identifier for the product.
(Definition from DEV.7 in Ch. 17)
Definition: This field contains the manufacturer's model identifier for the product.
(Definition from PDC.7 in Ch. 7)
Definition: This field contains the manufacturer's catalogue identifier for the product.
(Definition from DEV.8 in Ch. 17)
Definition: This field contains the manufacturer's catalogue identifier for the product.
(Definition from PRT.16 in Ch. 7)
Definition: Provides the U.S. FDA UDI device identifier (DI) element.
This is the first component in the UDI and acts as the look up key for the Global Unique Device Identification Database (GUDID3), and may be used for retrieving additional attributes.
When exchanging Device Identifiers (DI) the root shall be the OID, or standards’ appropriate corollary to the OID, assigned to DI and the extension shall be the Human Readable Form of the content. For example, for DIs the root shall be:
GS1 DIs: 2.51.1.1
HIBCC DIs: 1.0.15961.10.816
ICCBBA DIs: 2.16.840.1.113883.6.18.1.17 for Blood containers and 2.16.840.1.113883.6.18.1.34 otherwise.
Example: |00643169001763^^2.51.1.1^ISO|
(Definition from DEV.9 in Ch. 17)
Definition: Provides the U.S. FDA UDI device identifier (DI) element. This is not the same as DEV-2, Unique Device Identifier as DEV-2 represents either the full UDI Carrier in the case of an implantable Device,
This is the first component in the UDI and acts as the look up key for the Global Unique Device Identification Database (GUDID2), and may be used for retrieving additional attributes.
When exchanging Device Identifiers (DI) the root shall be the OID, or standards’ appropriate corollary to the OID, assigned to DI and the extension shall be the Human Readable Form of the content. For example, for DIs the root shall be:
GS1 DIs: 2.51.1.1
HIBCC DIs: 1.0.15961.10.816
ICCBBA DIs: 2.16.840.1.113883.6.18.1.17 for Blood containers and 2.16.840.1.113883.6.18.1.34 otherwise.
Example: |00643169001763^^2.51.1.1^ISO|
(Definition from PRT.19 in Ch. 7)
Definition: Alphanumeric string that identifies the device’s production lot number.
Example: |123ABC|
(Definition from DEV.10 in Ch. 17)
Definition: Alphanumeric string that identifies the device’s production lot number.
Example: |123ABC|
(Definition from PRT.20 in Ch. 7)
Definition: Manufacturer’s serial number for this device.
CAUTION: See the related privacy considerations discussion in PRT-10.
Example: |21A11F4855|
(Definition from DEV.11 in Ch. 17)
Definition: Manufacturer’s serial number for this device. This field may be the same as DEV-2, Unique Device Identifier when the device does not involve a UDI Carrier for UDI and DEV-2 represents a serial number. The implementation guide would determine whether DEV-11 is then used or not.
(Definition from PRT.17 in Ch. 7)
Definition: Date and time when the device was manufacturered.
Note: The user system may need to convert the date and optional hour from the UDI Human Readable Form to a timestamp style data type, augmenting the date as required to provide for a complete date and optionally the hour.
Example: |20140401|
(Definition from DEV.12 in Ch. 17)
Definition: Date and time when the device was manufacturered.
Note: The user system may need to convert the date and optional hour from the UDI Human Readable Form to a timestamp style data type, augmenting the date as required to provide for a complete date and optionally the hour.
Example: |20140401|
(Definition from PRT.18 in Ch. 7)
Definition: Date and time when the device is no longer approved for use.
Note: The user system may need to convert the date and optional hour from the UDI Human Readable Form to a timestamp style data type, augmenting the date as required to provide for a complete date and optionally the hour.
Example: |20160712|
(Definition from DEV.13 in Ch. 17)
Definition: Date and time when the device is no longer approved for use.
Note: The user system may need to convert the date and optional hour from the UDI Human Readable Form to a timestamp style data type, augmenting the date as required to provide for a complete date and optionally the hour.
Example: |20160712|
CAUTION: See the related privacy considerations discussion in PRT-10.
Example: |21A11F4855|
Definition: This field a safety characteristic of a device, e.g., latex safety, MRI safety.
See Externally HL7 defined 0963 in Chapter 2C for a suggested values.
(Definition from PRT.21 in Ch. 7)
Definition: Identifies a device related to a donation (e.g., whole blood).
When exchanging Donation Identification Numbers (DIN) the root shall be the OID assigned to DIN and the extension shall be the Human Readable Form of the content. For example, for DINs the root shall be:
ICCBBA DINs: 2.16.840.1.113883.6.18.2.1
An ICCBBA DIN OID is available for reference where required, but is not required when the specific data element is scoped to ICCBBA DINs.
Example: | RA12345678BA123^^2.16.840.1.113883.6.18.1.34^ISO|
(Definition from DEV.15 in Ch. 17)
Definition: Identifies a device related to a donation.
When exchanging Donation Identification Numbers (DIN) the root shall be the OID assigned to DIN and the extension shall be the Human Readable Form of the content. For example, for DINs the root shall be:
ICCBBA DINs: 2.16.840.1.113883.6.18.2.1
An ICCBBA DIN OID is available for reference where required, but is not required when the specific data element is scoped to ICCBBA DINs.
Example: | RA12345678BA123^^2.16.840.1.113883.6.18.1.34^ISO|
Definition: The version number of the software that is part of the device.
Definition: This field contains the implantation status of the device, e.g., implanted, explanted. Refer to HL7 Table 0795 – Implanatation Status in Chapter 2C for valid values.
®© HL7.org 2019+. HL7 v2+ generated on December 11, 2020
Links:
Version History
|
Propose a change
|
License
The Demo site for our new HL7 Version 2+ (plus) Standard
