<?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>e5798858-62ca-4a3e-b569-598a8d14ca58</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2026-09-18</publicVersionDate><devicePublishDate>2026-09-10</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B00972503</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>B00972500</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Cardboard Box</pkgType></identifier><identifier><deviceId>B00972500</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Organ Care System</brandName><versionModelNumber>1411</versionModelNumber><catalogNumber>1411</catalogNumber><dunsNumber>084445043</dunsNumber><companyName>TRANSMEDICS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>OCS Mobile Base</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>978-552-0900</phone><phoneExtension xsi:nil="true"/><email>xx@xx.xx</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>66882</gmdnCode><gmdnPTName>Surgical/procedural instrument trolley</gmdnPTName><gmdnPTDefinition>An open mobile cart intended to store and/or transport instruments for use during surgical and/or medical procedures within a hospital/institution department (e.g., transport between operating and central sterilization rooms). It is typically in the form of a table on wheels with an open shelf/platform underneath and may be used as a surface on which to place instruments in a hygienic manner during procedures. It does not include doors (i.e., not a cabinet). It is not intended to be used to perform procedures or for sterilization of instruments.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>QBA</productCode><productCodeName>Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation</productCodeName></fdaProductCode><fdaProductCode><productCode>QIK</productCode><productCodeName>Organ Care System (Ocs) Heart System</productCodeName></fdaProductCode><fdaProductCode><productCode>QQK</productCode><productCodeName>Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="21"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Inch" value="28"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Height</sizeType><size unit="Inch" value="10"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="KiloPascal" value="106"/><storageHandlingLow unit="KiloPascal" value="50"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="95"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="50"/><storageHandlingLow unit="Degrees Celsius" value="-20"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>