<?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>b2f70691-aba9-432a-9e9a-6fc4570aefe3</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2023-07-27</publicVersionDate><devicePublishDate>2015-06-08</devicePublishDate><deviceCommDistributionEndDate>2015-06-30</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>37332414106950</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>Mars Treatment Kit</brandName><versionModelNumber>800480</versionModelNumber><catalogNumber>800480</catalogNumber><dunsNumber>354021099</dunsNumber><companyName>GAMBRO AB</companyName><deviceCount>1</deviceCount><deviceDescription>The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing MARS therapy, with exclusive use being made of the MARS Monitor 1TC in combination with the Prisma Control Unit (produced by Gambro).</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>true</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)933-0303</phone><phoneExtension xsi:nil="true"/><email>Medinfo_medproducts@baxter.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K113313</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46212</gmdnCode><gmdnPTName>Bound solute dialysis system component set</gmdnPTName><gmdnPTDefinition>A collection of devices that typically include filters, tubing, and connectors used in a bound solute dialysis system for the removal of albumin-bound toxins (e.g., bile acids, bilirubin, heavy metals, phenols) from a patient&apos;s blood during extracorporeal blood purification, typically in persons suffering liver failure or poisoning/drug overdose. The items in this set are devices that function in association with a system pump/monitor. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FLD</productCode><productCodeName>Apparatus, Hemoperfusion, Sorbent</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep away from direct sunlight, water, and moisture. Do not store or transport at temperatures below freezing, since this might lead to mechanical damage.</storageHandlingSpecialConditionText></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="27"/><storageHandlingLow unit="Degrees Celsius" value="8"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>