Under pre-publication review| Description |
This template is intended to be used in addition to the **Product Instance** template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the **Device Identifier** (also known as the "Primary DI Number") for a medical device marketed in the US. The device identifier is parsed from the UDI value. The Device Identifier number can be used as a key to look-up device identification information in the publicly available version of the US FDA Global UDI Database (GUDID) - the AccessGUDID: https://accessgudid.nlm.nih.gov/resources/home |
| Used by 0 transactions and 1 template, Uses 0 templates | ||||||||
|
ref
ad1bbr-
| Device Identifier |
| <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.304" extension="2019-06-21"/> <code code="C101722" displayName="Primary DI Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/> <!-- GS1 Device Identifier --> <value xsi:type="II" root="1.3.160" extension="00999998998989" displayable="true" assigningAuthorityName="GS1"/></observation> |
| Item | DT | Card | Conf | Description | Label |
|---|---|---|---|---|---|
| cda:observation | Devi tion | ||||
| @nullFlavor | cs | 0 … 1 | MAY contain zero or one [0..1] @nullFlavor (CONF:X-X). | ||
| @classCode | cs | 1 … 1 | R | SHALL contain exactly one [1..1] @classCode (CONF:X-X). | |
| @moodCode | cs | 1 … 1 | R | SHALL contain exactly one [1..1] @moodCode (CONF:X-X). | |
| @negationInd | bl | 0 … 1 | MAY contain zero or one [0..1] @negationInd (CONF:X-X). | ||
| cda:realmCode | 0 … * | MAY contain zero or more [0..*] realmCode (CONF:X-X). | Devition | ||
| cda:typeId | 0 … 1 | MAY contain zero or one [0..1] typeId (CONF:X-X). | Devition | ||
| cda:templateId | 1 … 1 | M | SHALL contain exactly one [1..1] templateId (CONF:4437-3421). | CONF3421 | |
| @root | uid | 1 … 1 | F | 2.16.840.1.113883.10.20.22.4.304 | CONF3424 |
| This templateId SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.304" (CONF:4437-3424). | |||||
| @extension | st | 1 … 1 | F | 2019-06-21 | CONF3425 |
| This templateId SHALL contain exactly one [1..1] @extension="2019-06-21" (CONF:4437-3425).Revision from "2018-05-01" | |||||
| cda:id | 0 … * | MAY contain zero or more [0..*] id (CONF:X-X). | Devition | ||
| cda:code | 1 … 1 | M | SHALL contain exactly one [1..1] code (CONF:4437-3422). | CONF3422 | |
| @codeSystemName | 0 … 1 | F | NCI Thesaurus | CONF3428 | |
| This code MAY contain zero or one [0..1] @codeSystemName="NCI Thesaurus" (CONF:4437-3428). | |||||
| @displayName | 0 … 1 | F | Primary DI Number | CONF3429 | |
| This code MAY contain zero or one [0..1] @displayName="Primary DI Number" (CONF:4437-3429). | |||||
| @code | CONF | 1 … 1 | F | C101722 | |
| @codeSystem | 1 … 1 | F | 2.16.840.1.113883.3.26.1.1 | ||
| cda:derivationExpr | 0 … 1 | MAY contain zero or one [0..1] derivationExpr (CONF:X-X). | Devition | ||
| cda:text | 0 … 1 | MAY contain zero or one [0..1] text (CONF:X-X). | Devition | ||
| cda:statusCode | 0 … 1 | MAY contain zero or one [0..1] statusCode (CONF:X-X). | Devition | ||
| cda:effectiveTime | 0 … 1 | MAY contain zero or one [0..1] effectiveTime (CONF:X-X). | Devition | ||
| cda:priorityCode | 0 … 1 | MAY contain zero or one [0..1] priorityCode (CONF:X-X). | Devition | ||
| cda:repeatNumber | 0 … 1 | MAY contain zero or one [0..1] repeatNumber (CONF:X-X). | Devition | ||
| cda:languageCode | 0 … 1 | MAY contain zero or one [0..1] languageCode (CONF:X-X). | Devition | ||
| cda:value | II | 1 … 1 | M | SHALL contain exactly one [1..1] value with @xsi:type="II" (CONF:4437-3423).The value of the Device Identifier assigned using one of the FDA-accredited, UDI issuing agency: GS1, HIBCC, or ICBBA. | CONF3423 |
| @root | uid | 1 … 1 | R | This value SHALL contain exactly one [1..1] @root (CONF:4437-3430).The "root" specifies the assigning authority, i.e, the UDI issuing agency. The allowable OIDs include: * 1.3.160 (GS1) * 2.16.840.1.113883.6.18 (ICCBBA - ISBT-128) * 2.16.840.1.113883.6.40 (HIBCC) | CONF3430 |
| @extension | st | 1 … 1 | R | This value SHALL contain exactly one [1..1] @extension (CONF:4437-3431).The value of the Device Identifier. | CONF3431 |
| @displayable | 1 … 1 | F | true | CONF3540 | |
| This value SHALL contain exactly one [1..1] @displayable="true" (CONF:4437-3540).The Device Identifier can be used to look up device information entered by manufacturers in the FDA GUDID | |||||
| cda:interpretationCode | 0 … * | MAY contain zero or more [0..*] interpretationCode (CONF:X-X). | Devition | ||
| cda:methodCode | 0 … * | MAY contain zero or more [0..*] methodCode (CONF:X-X). | Devition | ||
| cda:targetSiteCode | 0 … * | MAY contain zero or more [0..*] targetSiteCode (CONF:X-X). | Devition | ||
| cda:subject | 0 … 1 | MAY contain zero or one [0..1] subject (CONF:X-X). | Devition | ||
| cda:specimen | 0 … * | MAY contain zero or more [0..*] specimen (CONF:X-X). | Devition | ||
| cda:performer | 0 … * | MAY contain zero or more [0..*] performer (CONF:X-X). | Devition | ||
| cda:author | 0 … * | MAY contain zero or more [0..*] author (CONF:X-X). | Devition | ||
| cda:informant | 0 … * | MAY contain zero or more [0..*] informant (CONF:X-X). | Devition | ||
| cda:participant | 0 … * | MAY contain zero or more [0..*] participant (CONF:X-X). | Devition | ||
| cda:entryRelationship | 0 … * | MAY contain zero or more [0..*] entryRelationship (CONF:X-X). | Devition | ||
| cda:reference | 0 … * | MAY contain zero or more [0..*] reference (CONF:X-X). | Devition | ||
| cda:precondition | 0 … * | MAY contain zero or more [0..*] precondition (CONF:X-X). | Devition | ||
| sdtc:precondition2 | 0 … * | MAY contain zero or more [0..*] sdtc:precondition2 (CONF:X-X). | Devition | ||
| cda:referenceRange | 0 … * | MAY contain zero or more [0..*] referenceRange (CONF:X-X). | Devition | ||
| sdtc:inFulfillmentOf1 | 0 … * | MAY contain zero or more [0..*] sdtc:inFulfillmentOf1 (CONF:X-X). | Devition | ||