<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>48b6f24b-8a6a-4d7b-b097-450a28e4464d</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2022-06-10</publicVersionDate><devicePublishDate>2020-07-27</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00889858617543</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>CardioGRAFT-MC™</brandName><versionModelNumber>DPPGK7032</versionModelNumber><catalogNumber>DPPGK</catalogNumber><dunsNumber>121828156</dunsNumber><companyName>LIFENET HEALTH</companyName><deviceCount>1</deviceCount><deviceDescription>Decellularized Pulmonary Artery Patch - Thick</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>true</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>61625</gmdnCode><gmdnPTName>Cadaveric pulmonary artery bioprosthesis</gmdnPTName><gmdnPTDefinition>An implantable heart tissue allograft obtained from a human cadaver intended to be implanted in the heart during open heart surgery, to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be supplied in various configurations including pulmonary hemi-artery, pulmonary trunk and pulmonary branch.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DXZ</productCode><productCodeName>Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="70"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="32"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>