Id2.16.840.1.113883.10.20.22.4.311Effective Date2019‑06‑21
Statuspending Under pre-publication reviewVersion LabelC-CDA R2.1
NameUDIOrganizerDisplay NameUDI Organizer
Description
This template is used to manage all the UDI-related templates to exchange the parsed UDI data elements and associated data: * **Device Identifier** urn:hl7ii:2.16.840.1.113883.10.20.22.4.304: 2019-06-21 NCIt: C101722 SHALL be included in UDI Organizer * **Lot or Batch Number** urn:hl7ii:2.16.840.1.113883.10.20.22.4.315: 2019-06-21 NCIt:C101672 SHOULD be included in UDI Organizer if present in UDI * **Serial Number** urn:hl7ii:2.16.840.1.113883.10.20.22.4.319: 2019-06-21 NCIt: C101671 SHOULD be included in UDI Organizer if present in UDI * **Manufacturing Date** urn:hl7ii:2.16.840.1.113883.10.20.22.4.316: 2019-06-21 NCIt:C101669 SHOULD be included in UDI Organizer if present in UDI * **Expiration Date** urn:hl7ii:2.16.840.1.113883.10.20.22.4.309: 2019-06-21 NCIt: C101670 SHOULD be included in UDI Organizer if present in UDI * **Distinct Identification Code** urn:hl7ii:2.16.840.1.113883.10.20.22.4.308: 2019-06-21 NCIt: C113843 SHOULD be included in UDI Organizer if present in UDI * **Brand Name** urn:hl7ii:2.16.840.1.113883.10.20.22.4.301: 2019-06-21 NCIt: C71898 MAY be included in the UDI Organizer if available * **Model Number** urn:hl7ii:2.16.840.1.113883.10.20.22.4.317: 2019-06-21 NCIt: C99285 MAY be included in the UDI Organizer if available * **Catalog Number** urn:hl7ii:2.16.840.1.113883.10.20.22.4.302: 2019-06-21 NCIt: C99286 MAY be included in the UDI Organizer if available * **Company Name** urn:hl7ii:2.16.840.1.113883.10.20.22.4.303: 2019-06-21 NCIt: C54131 MAY be included in the UDI Organizer if available * **MRI Safety** urn:hl7ii:2.16.840.1.113883.10.20.22.4.318: 2019-06-21 NCIt: C106044 MAY be included in the UDI Organizer if available * **Latex Safety** urn:hl7ii:2.16.840.1.113883.10.20.22.4.314: 2019-06-21 NCIt: C160938 MAY be included in the UDI Organizer if available * **Implantable Device Status** urn:hl7ii:2.16.840.1.113883.10.20.22.4.305 2019-06-21 NCIt: C160939 MAY be included in the UDI Organizer if available
ContextParent nodes of template element with id 2.16.840.1.113883.10.20.22.4.311
ClassificationCDA Entry Level Template
Open/ClosedOpen (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 0 templates, Uses 13 templates
Uses as NameVersion
2.16.840.1.113883.10.20.22.4.301Containmentpending Brand Name Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.302Containmentpending Catalog Number Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.303Containmentpending Company Name Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.304Containmentpending Device Identifier Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.305Containmentpending Implantable Device Status Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.308Containmentpending Distinct Identification Code Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.309Containmentpending Expiration Date Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.314Containmentpending Latex Safety Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.315Containmentpending Lot or Batch Number Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.316Containmentpending Manufacturing Date Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.317Containmentpending Model Number Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.318Containmentpending MRI Safety Observation (C-CDA R2.1)2019‑06‑21
2.16.840.1.113883.10.20.22.4.319Containmentpending Serial Number Observation (C-CDA R2.1)2019‑06‑21
RelationshipSpecialization: template 2.16.840.1.113883.10.12.305 CDA Organizer (2005‑09‑07)
ref
ad1bbr-
Example
Unique Device Identifier (UDI) Organizer
<!-- UDI Organizer -->
<organizer classCode="CLUSTER" moodCode="EVN">
  <templateId root="2.16.840.1.113883.10.20.22.4.312" extension="2019-06-21"/>  <id assigningAuthorityName="FDA" extension="(01)4328998989(11)160330(10)ABC124" root="GS1"/>  <code code="74711-3" codeSystem="2.16.840.1.113883.6.1" displayName="Unique Device Identifier"/>  <statusCode code="completed"/>  <!-- UDI components -->
  <component>
    <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="99994328998989" displayable="true" assigningAuthorityName="GS1"/>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.315" extension="2019-06-21"/>      <code code="C101672" displayName="Lot or Batch Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="ED">
        <reference value="#LotOrBatchNumber_1"/>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.319" extension="2019-06-21"/>      <code code="C101671" displayName="Serial Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="ED">
        <reference value="#SerialNumber_1"/>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.316" extension="2019-06-21"/>      <code code="C101669" displayName="Manufacturing Date" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="TS" value="20181015"/>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.309" extension="2019-06-21"/>      <code code="C101670" displayName="Expiration Date" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="TS" value="20221015"/>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.308" extension="2019-06-21"/>      <code code="C113843" displayName="Distinct Identification Code" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="ED">
        <reference value="#DistinctIdentificationCode_1"/>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.301" extension="2019-06-21"/>      <code code="C71898" displayName="Brand Name" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="ED">
        <reference value="#BrandName_1"/>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.317" extension="2019-06-21"/>      <code code="C99285" displayName="Model Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="ED">
        <reference value="#ModelNumber_1"/>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.302" extension="2019-06-21"/>      <code code="C99286" displayName="Catalog Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="ED">
        <reference value="#CatalogNumber_1"/>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.303" extension="2019-06-21"/>      <code code="C54131" displayName="Company Name" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="ED">
        <reference value="#CompanyName_1"/>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.318" extension="2019-06-21"/>      <code code="C106044" displayName="MRI Safety Status" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="CD" code="C113844" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Labeling does not contain MRI Safety Information" codeSystemName="NCI Thesaurus" sdtc:valueSet="2.16.840.1.113762.1.4.1021.46">
        <originalText>
          <reference value="#MRISafety_1"/>        </originalText>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.314" extension="2019-06-21"/>      <code code="C160938" displayName="Latex Safety Status" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="CD" code="C106038" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Not Made with Natural Rubber Latex" codeSystemName="NCI Thesaurus" sdtc:valueSet="2.16.840.1.113762.1.4.1021.47">
        <originalText>
          <reference value="#LatexSafety_1"/>        </originalText>      </value>    </observation>  </component>  <component>
    <observation classCode="OBS" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.305" extension="2019-06-21"/>      <code code="C160939" displayName="Implantable Device Status" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>      <value xsi:type="CD" code="C160942" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Reduced Function" codeSystemName="NCI Thesaurus" sdtc:valueSet="2.16.840.1.113762.1.4.1021.48">
        <originalText>
          <reference value="#ImplantableDeviceStatus_1"/>        </originalText>      </value>    </observation>  </component></organizer>
ItemDTCardConfDescriptionLabel
cda:organizer
UDIOdotsizer
@nullFlavor
cs0 … 1 MAY contain zero or one [0..1] @nullFlavor (CONF:X-X).
@classCode
cs1 … 1RSHALL contain exactly one [1..1] @classCode (CONF:X-X).
@moodCode
cs1 … 1RSHALL contain exactly one [1..1] @moodCode (CONF:X-X).
cda:realmCode
0 … *MAY contain zero or more [0..*] realmCode (CONF:X-X).UDIOdotsizer
cda:typeId
0 … 1MAY contain zero or one [0..1] typeId (CONF:X-X).UDIOdotsizer
cda:templateId
1 … 1MSHALL contain exactly one [1..1] templateId (CONF:4437-3480) such that itCONFdots3480
@root
uid1 … 1F2.16.840.1.113883.10.20.22.4.311CONFdots3484
 SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.311" (CONF:4437-3484).
@extension
st1 … 1F2019-06-21CONFdots3485
 SHALL contain exactly one [1..1] @extension="2019-06-21" (CONF:4437-3485).

Revision from "2018-05-01".
cda:id
1 … 1MSHALL contain exactly one [1..1] id (CONF:4437-3541).

The UDI Organizer identifier shall match the Product Instance identifier value. The identifier will tie the specific UDI information to an individual product instance.		CONFdots3541
@root
uid1 … 1RThis id SHALL contain exactly one [1..1] @root (CONF:4437-3542).CONFdots3542
cda:code
0 … 1MAY contain zero or one [0..1] code (CONF:4437-3481).CONFdots3481
@code
CONF0 … 1F74711-3
@codeSystem
0 … 1F2.16.840.1.113883.6.1
sdtc:text
0 … 1MAY contain zero or one [0..1] sdtc:text (CONF:X-X).UDIOdotsizer
cda:statusCode
1 … 1MSHALL contain exactly one [1..1] statusCode (CONF:4437-3490).

This is the status of the UDI Organizer. The value if fixed to "completed".		CONFdots3490
@code
CONF1 … 1Fcompleted
cda:effectiveTime
0 … 1MAY contain zero or one [0..1] effectiveTime (CONF:X-X).UDIOdotsizer
cda:subject
0 … 1MAY contain zero or one [0..1] subject (CONF:X-X).UDIOdotsizer
cda:specimen
0 … *MAY contain zero or more [0..*] specimen (CONF:X-X).UDIOdotsizer
cda:performer
0 … *MAY contain zero or more [0..*] performer (CONF:X-X).UDIOdotsizer
cda:author
0 … *MAY contain zero or more [0..*] author (CONF:X-X).UDIOdotsizer
cda:informant
0 … *MAY contain zero or more [0..*] informant (CONF:X-X).UDIOdotsizer
cda:participant
0 … *MAY contain zero or more [0..*] participant (CONF:X-X).UDIOdotsizer
cda:reference
0 … *MAY contain zero or more [0..*] reference (CONF:X-X).UDIOdotsizer
cda:precondition
0 … *MAY contain zero or more [0..*] precondition (CONF:X-X).UDIOdotsizer
sdtc:precondition2
0 … *MAY contain zero or more [0..*] sdtc:precondition2 (CONF:X-X).UDIOdotsizer
cda:component
1 … 1MSHALL contain exactly one [1..1] component (CONF:4437-3488) such that it

**Device Identifier** - the mandatory part of the UDI

SHALL contain exactly one [1..1] Device Identifier Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.304:2019-06-21) (CONF:4437-3489).
Contains 2.16.840.1.113883.10.20.22.4.304 Device Identifier Observation (2019‑06‑21)		CONFdots3488
cda:component
0 … 1RSHOULD contain zero or one [0..1] component (CONF:4437-3513) such that it

**Lot or Batch Number** - needed if present as a production identifier

SHALL contain exactly one [1..1] Lot or Batch Number Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.315:2019-06-21) (CONF:4437-3514).
Contains 2.16.840.1.113883.10.20.22.4.315 Lot or Batch Number Observation (2019‑06‑21)		CONFdots3513
cda:observation
1 … 1MSHALL contain exactly one [1..1] Lot or Batch Number Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.315:2019-06-21) (CONF:4437-3514).CONFdots3514
cda:component
0 … 1RSHOULD contain zero or one [0..1] component (CONF:4437-3515) such that it

**Serial Number** - needed if present as a production identifier

SHALL contain exactly one [1..1] Serial Number Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.319:2019-06-21) (CONF:4437-3516).
Contains 2.16.840.1.113883.10.20.22.4.319 Serial Number Observation (2019‑06‑21)		CONFdots3515
cda:component
0 … 1RSHOULD contain zero or one [0..1] component (CONF:4437-3517) such that it

**Manufacturing Date** - needed if present as a production identifier

SHALL contain exactly one [1..1] Manufacturing Date Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.316:2019-06-21) (CONF:4437-3518).
Contains 2.16.840.1.113883.10.20.22.4.316 Manufacturing Date Observation (2019‑06‑21)		CONFdots3517
cda:component
0 … 1RSHOULD contain zero or one [0..1] component (CONF:4437-3525) such that it

**Expiration Date** - needed if present as a production identifier

SHALL contain exactly one [1..1] Expiration Date Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.309:2019-06-21) (CONF:4437-3526).
Contains 2.16.840.1.113883.10.20.22.4.309 Expiration Date Observation (2019‑06‑21)		CONFdots3525
cda:component
0 … 1RSHOULD contain zero or one [0..1] component (CONF:4437-3523) such that it

**Distinct Identification Code** - needed if present as a production identifier for HCT/P regulated as medical devices.

SHALL contain exactly one [1..1] Distinct Identification Code Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.308:2019-06-21) (CONF:4437-3524).
Contains 2.16.840.1.113883.10.20.22.4.308 Distinct Identification Code Observation (2019‑06‑21)		CONFdots3523
cda:component
0 … 1MAY contain zero or one [0..1] component (CONF:4437-3521) such that it

**Brand Name** - when it was extracted from accessGUDID at the time the information was entered in the patient's record.

SHALL contain exactly one [1..1] Brand Name Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.301:2019-06-21) (CONF:4437-3522).
Contains 2.16.840.1.113883.10.20.22.4.301 Brand Name Observation (2019‑06‑21)		CONFdots3521
cda:component
0 … 1MAY contain zero or one [0..1] component (CONF:4437-3519) such that it

**Model Number** - when it was extracted from accessGUDID at the time the information was entered in the patient's record.

SHALL contain exactly one [1..1] Model Number Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.317:2019-06-21) (CONF:4437-3520).
Contains 2.16.840.1.113883.10.20.22.4.317 Model Number Observation (2019‑06‑21)		CONFdots3519
cda:component
0 … 1MAY contain zero or one [0..1] component (CONF:4437-3535) such that it

**Company Name** - the name of the company that manufactured the device when it was extracted from accessGUDID at the time the information was entered in the patient's record.

SHALL contain exactly one [1..1] Company Name Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.303:2019-06-21) (CONF:4437-3536).
Contains 2.16.840.1.113883.10.20.22.4.303 Company Name Observation (2019‑06‑21)		CONFdots3535
cda:component
0 … 1MAY contain zero or one [0..1] component (CONF:4437-3527) such that it

**Catalog Number** - specified by manufacturer or when it was extracted from accessGUDID at the time the information was entered in the patient's record.

SHALL contain exactly one [1..1] Catalog Number Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.302:2019-06-21) (CONF:4437-3528).
Contains 2.16.840.1.113883.10.20.22.4.302 Catalog Number Observation (2019‑06‑21)		CONFdots3527
cda:component
0 … 1MAY contain zero or one [0..1] component (CONF:4437-3529) such that it

**Latex Safety Status** when it was extracted from accessGUDID at the time the information was entered in the patient's record.

SHALL contain exactly one [1..1] Latex Safety Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.314:2019-06-21) (CONF:4437-3530).
Contains 2.16.840.1.113883.10.20.22.4.314 Latex Safety Observation (2019‑06‑21)		CONFdots3529
cda:component
0 … 1MAY contain zero or one [0..1] component (CONF:4437-3533) such that it

**MRI Safety Status** when it was extracted from accessGUDID at the time the information was entered in the patient's record.

SHALL contain exactly one [1..1] MRI Safety Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.318:2019-06-21) (CONF:4437-3534).
Contains 2.16.840.1.113883.10.20.22.4.318 MRI Safety Observation (2019‑06‑21)		CONFdots3533
cda:component
0 … 1MAY contain zero or one [0..1] component (CONF:4437-3531) such that it

**Implantable Device Status** - the status of the device in the body of the patient, it augments the information in **@status.**

SHALL contain exactly one [1..1] Implantable Device Status Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.305:2019-06-21) (CONF:4437-3532).
Contains 2.16.840.1.113883.10.20.22.4.305 Implantable Device Status Observation (2019‑06‑21)		CONFdots3531