CDA Examples, published by Health Level Seven. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CDA-Examples/ and changes regularly. See the Directory of published versions
This is an example of how to record the full details of a UDI. This examples follows the design in Appendix B of the 2019 C-CDA Companion Guide.
This file includes examples of the following templates:
<section xmlns="urn:hl7-org:v3">
<templateId root="2.16.840.1.113883.10.20.22.2.23" extension="2014-06-09"/>
<templateId root="2.16.840.1.113883.10.20.22.2.23"/>
<code codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"
code="46264-8"/>
<title>Medical Equipment</title>
<text>
<table>
<colgroup>
<col width="40%"/>
<col width="20%"/>
<col width="40%"/>
</colgroup>
<tbody>
<tr ID="_9d1b9efd-baff-45b2-8033-cdf2fc02c35f">
<td>
<content ID="_d92f7e16-385c-4079-b9c8-adfb2525ef6c">Breast Implant</content>
</td>
<td>
<content>Date: </content>
<content>14-Jul-2020</content>
<br/>
</td>
<td/>
</tr>
<tr ID="_2350e0a1-5ffb-4b6d-ba9f-be489d9dfc2f">
<td>
<content> •</content>
<content>
<content ID="BrandName_1">Example BrandName</content>
<br/>
<content ID="CompanyName_1">Example Company Name</content>
<br/>
<content>(GS1)00848486001048</content>
<br/>
<content>Serial: </content>
<content ID="SerialNumber_1">bi12342222</content>
<br/>
</content>
</td>
<td>
<content>Expires: </content>
<content>15-Oct-2022</content>
<br/>
<content>Mfd: </content>
<content>15-Oct-2018</content>
<br/>
<content>Model: </content>
<content ID="ModelNumber_1">Example Model Number</content>
<br/>
<br/>
<content>Catalog Number: </content>
<content ID="CatalogNumber_1">Example Catalog Number</content>
<br/>
<content>Lot: </content>
<content>ABC999</content>
<br/>
</td>
<td>
<content>Overall Status: </content>
<content>Breast Implant (L)</content>
<br/>
<content>Implant Status: </content>
<content ID="ImplantableDeviceStatus_1">Implantable DeviceStatus Text</content>
<br/>
<content>MRI: </content>
<content ID="MRISafety_1">Labeling does not contain MRI Safety Information</content>
<br/>
<content>Latex: </content>
<content ID="LatexSafety_1">Not Made with Natural Rubber Latex</content>
<br/>
</td>
</tr>
</tbody>
</table>
</text>
<entry>
<procedure moodCode="EVN" classCode="PROC">
<templateId root="2.16.840.1.113883.10.20.22.4.14"
extension="2024-05-01"/>
<templateId root="2.16.840.1.113883.10.20.22.4.14"
extension="2014-06-09"/>
<templateId root="2.16.840.1.113883.10.20.22.4.14"/>
<id root="1.2.840.114350.1.13.5552.1.7.2.737780" extension="6239942"/>
<!-- The procedure that supported the implant is unknown -->
<!-- A patient may be informing provider of a historical implant -->
<code nullFlavor="UNK"/>
<text>
<reference value="#_9d1b9efd-baff-45b2-8033-cdf2fc02c35f"/>
</text>
<!-- Procedure is completed, even though the implant is still active -->
<statusCode code="completed"/>
<!-- time stamp as a point in time -->
<effectiveTime value="20200714"/>
<!-- Product Instance Template -->
<participant typeCode="DEV">
<participantRole classCode="MANU">
<templateId root="2.16.840.1.113883.10.20.22.4.37"/>
<!-- Full HRF UDI value from GS1, which is a UDI issuing agency: (01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015 -->
<!-- The order of the GS1 delimiters (01)..(11)... may vary -->
<!-- Device Identifier (01) - 00848486001048 -->
<!-- Manufacturing date (11) - 181015 -->
<!-- Lot or Batch Number (10) - ABC999 -->
<!-- Serial Number (21) - bi12342222 -->
<!-- Expiration Date (17) - 221015 -->
<!-- The entire UDI as a single string is scoped by the FDA OID: 2.16.840.1.113883.3.3719 -->
<id root="2.16.840.1.113883.3.3719"
extension="(01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015" assigningAuthorityName="FDA"/>
<playingDevice>
<code displayName="Breast Implant" codeSystemName="SNOMED CT"
codeSystem="2.16.840.1.113883.6.96" code="2282003">
<!-- Add original text with device type to playingDevice.code -->
<originalText>
<reference value="#_d92f7e16-385c-4079-b9c8-adfb2525ef6c"/>
</originalText>
</code>
</playingDevice>
<!-- From Product Instance template: The scopingEntity/id should correspond to FDA or the appropriate issuing agency. -->
<scopingEntity>
<id root="2.16.840.1.113883.3.3719"/>
</scopingEntity>
</participantRole>
</participant>
<entryRelationship typeCode="COMP">
<!-- UDI Organizer -->
<organizer moodCode="EVN" classCode="CLUSTER">
<templateId root="2.16.840.1.113883.10.20.22.4.311"
extension="2019-06-21"/>
<!-- UDI organizer/id matches the participantRole/id -->
<!-- The organizer splits the full HRF UDI value from GS1 into component observations -->
<id root="2.16.840.1.113883.3.3719"
extension="(01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015" assigningAuthorityName="FDA"/>
<code displayName="Unique Device Identifier"
codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1" code="74711-3"/>
<sdtc:sdtcText xmlns:sdtc="urn:hl7-org:sdtc">
<reference value="#_2350e0a1-5ffb-4b6d-ba9f-be489d9dfc2f"/>
</sdtc:sdtcText>
<statusCode code="completed"/>
<!-- Device Identifier -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.304"
extension="2019-06-21"/>
<templateId root="2.16.840.1.113883.10.20.22.4.304"
extension="2022-06-01"/>
<code xsi:type="CD" displayName="Primary DI Number"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101722"/>
<value xsi:type="II" root="1.3.160" extension="00848486001048"
displayable="true" assigningAuthorityName="GS1"/>
</observation>
</component>
<!-- Lot or Batch Number -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.315"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Lot or Batch Number"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101672"/>
<!-- Errata logged with Structured Documents to consider ED -->
<value xsi:type="ED">ABC999</value>
</observation>
</component>
<!-- Serial Number -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.319"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Serial Number"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101671"/>
<value xsi:type="ED">
<reference value="#SerialNumber_1"/>
</value>
</observation>
</component>
<!-- Manufacturing Date -->
<!-- If the value is parsed from UDI the format is YYMMDD and is transformed to YYYYMMDD. -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.316"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Manufacturing Date"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101669"/>
<value xsi:type="TS" value="20181015"/>
</observation>
</component>
<!-- Expiration Date -->
<!-- If the value is parsed from UDI the format is YYMMDD and is transformed to YYYYMMDD. -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.309"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Expiration Date"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101670"/>
<value xsi:type="TS" value="20221015"/>
</observation>
</component>
<!-- Distinct Identification assigned wherever donation pulled from -->
<!-- The distinct identification code may be equivalent to the serial number, lot or batch number, or the donation identification number. -->
<!-- The appropriate value should be provided as the distinct identification code. -->
<!-- <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" codeSystem="2.16.840.1.113883.3.26.1.1"
displayName="Distinct Identification" codeSystemName="NCI Thesaurus" />
<value xsi:type="ST">1111</value>
</observation>
</component> -->
<!-- Brand Name -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.301"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Brand Name"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C71898"/>
<value xsi:type="ED">
<reference value="#BrandName_1"/>
</value>
</observation>
</component>
<!-- Model Number -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.317"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Model Number"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C99285"/>
<value xsi:type="ED">
<reference value="#ModelNumber_1"/>
</value>
</observation>
</component>
<!-- Company Name -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.303"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Company Name"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C54131"/>
<value xsi:type="ED">
<reference value="#CompanyName_1"/>
</value>
</observation>
</component>
<!-- Catalog Number -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.302"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Catalog Number"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C99286"/>
<value xsi:type="ED">
<reference value="#CatalogNumber_1"/>
</value>
</observation>
</component>
<!-- Latex Safety -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.314"
extension="2019-06-21"/>
<code xsi:type="CD" displayName="Latex Safety Status"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C160938"/>
<value xsi:type="CD"
displayName="Not Made with Natural Rubber Latex" codeSystemName="NCI Thesaurus"
codeSystem="2.16.840.1.113883.3.26.1.1" code="C106038">
<originalText>
<reference value="#LatexSafety_1"/>
</originalText>
</value>
</observation>
</component>
<!-- MRI Safety Status -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.318"
extension="2019-06-21"/>
<code xsi:type="CD" codeSystem="2.16.840.1.113883.3.26.1.1"
code="C106044"/>
<value xsi:type="CD"
displayName="Labeling does not Contain MRI Safety Information" codeSystemName="NCI Thesaurus"
codeSystem="2.16.840.1.113883.3.26.1.1" code="C113844">
<originalText>
<reference value="#MRISafety_1"/>
</originalText>
</value>
</observation>
</component>
<!-- Device Status Implanted -->
<component>
<observation moodCode="EVN" classCode="OBS">
<templateId root="2.16.840.1.113883.10.20.22.4.305"
extension="2019-06-21"/>
<code xsi:type="CD" codeSystem="2.16.840.1.113883.3.26.1.1"
code="C160939"/>
<value xsi:type="CD" displayName="Active"
codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C45329">
<originalText>
<reference value="#ImplantableDeviceStatus_1"/>
</originalText>
</value>
</observation>
</component>
</organizer>
</entryRelationship>
</procedure>
</entry>
</section>