Implant UDI Unknown

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Approval Status

  • Approval Status: Approved
  • Example Task Force: 7/27/2017
  • SDWG: 10/5/2017

C-CDA 2.1 Example:

  • 2.16.840.1.113883.
  • 2.16.840.1.113883.

Reference to full CDA sample:

  • Results in empty CCD

Validation location


  • This is an example of a medical equipment section containing an implantable device where the full unique device identifier (UDI) is unknown.


  • May Terry, (GitHub: mayterry88)


  • ONC


  • multiple implants




Example: download example view on GitHub

<!-- This is meant to represent multiple implants during the same procedure and where one of the procedures has an unknown UDI. -->
<!-- This is not necessarily an ideal modeling and other changes to transition away from procedure act may be in future -->
<!-- That said, this is designed for compliance with current C-CDA 1.1 & 2.1 (and MU rules) -->
<!-- Note: This is current state and only representative of the UDI unknown. An example of multiple implants which includes UDI unknown will be release. -->
  <templateId root="2.16.840.1.113883."/>
  <templateId root="2.16.840.1.113883." extension="2014-06-09"/>
  <code code="46264-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Medical Equipment"/>
          <th>Device Type</th>  <!-- This is the generic name of the device. -->
          <th>Procedure Site</th>  
          <th>Implant Date</th>  <!-- separated out implant date -->
          <th>Provider Name and Organization</th>  
          <td ID="implantDevice1">Cardiac pacemaker</td> 
          <td ID="procedureCodeTextReference1">Insertion of intracardiac pacemaker</td>
          <td ID="procedureSiteCodeReference1">Structure of upper chest wall</td>
          <td/>  <!-- Laterality not appropriate for this device. -->
          <td>Winston, Harry</td>
  <!-- An example where the UDI is unknown or unavailable.  In this scenario,
      the patient asserts that a pacemaker was inserted 5 years ago.  -->
    <procedure classCode="PROC" moodCode="EVN">
      <templateId root="2.16.840.1.113883."/>
      <templateId root="2.16.840.1.113883." extension="2014-06-09"/>
      <!-- This a different procedure at the same facility, so the extension is different while the root is the same -->
      <id extension="1122334455" root="1.2.840.114350.1.13.5552."/>
      <code code="25267002" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" displayName="Insertion of intracardiac pacemaker">
          <reference value="#procedureCodeTextReference1"/> 
      <!-- Procedure is completed, even though the implant is still active -->
      <statusCode code="completed"/>
        <!-- Placed Date -->
        <low value="2012"/>
      <targetSiteCode code="699646004" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Structure of upper chest wall">
          <reference value="#procedureSiteCodeReference1"/> 
      <performer typeCode="PRF"> 
          <id extension="2222222222" root="2.16.840.1.113883.4.6" />
            <streetAddressLine>123 Any Street</streetAddressLine>
            <streetAddressLine>Suite 101</streetAddressLine>
          <telecom value="tel:+1-(555)555-1234" />
      <!-- The informant is identified as the patient. -->
          <id extension="12345" root="1.2.840.114350.1.13.5552." />
          <!-- the informant is the patient -->
          <code code="ONESELF" displayName="self" codeSystem="2.16.840.1.113883.5.111" codeSystemName="HL7 Role code" /> 
          <addr use="HP">
            <streetAddressLine>222 Home Street</streetAddressLine>
          <telecom value="tel:(555)555-2004" use="HP" />
      <participant typeCode="DEV">
        <participantRole classCode="MANU">
          <templateId root="2.16.840.1.113883."/> 
          <id root="2.16.840.1.113883.3.3719" nullFlavor="NI" /> <!-- There is no UDI information available --> 
            <code nullFlavor="OTH"> <!-- Vendor doesn't code specific device. --> 
                <reference value="#implantDevice1"/>
            <id root="2.16.840.1.113883.3.3719"/>  <!-- The FDA is the issuing agency as a default. -->
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