<?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>75a31da4-0c99-4937-9f04-d400414c5163</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2018-03-29</publicVersionDate><devicePublishDate>2015-06-08</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>37332414106936</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 Monitor </brandName><versionModelNumber>800437</versionModelNumber><catalogNumber>800437</catalogNumber><dunsNumber>354021099</dunsNumber><companyName>GAMBRO AB</companyName><deviceCount>1</deviceCount><deviceDescription>The MARS Monitor is a mechanical detoxification device used in conjunction with a renal replacement therapy system (companion device) for the removal of dialyzable (unbound) toxins, which are either water-soluble or, in the bound form, associated with serum albumin. 
</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>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><gmdnTerms><gmdn><gmdnCode>46214</gmdnCode><gmdnPTName>Bound solute dialysis system pump/monitor</gmdnPTName><gmdnPTDefinition>A mains electricity (AC-powered) device that is a component of a bound solute dialysis system and used to control the circulation of a high-concentration albumin dialysate through a filter, to bind and remove 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. It uses a dedicated set of filters, tubing, and connectors and may be controlled by dedicated application software.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FLD</productCode><productCodeName>Apparatus, Hemoperfusion, Sorbent</productCodeName></fdaProductCode><fdaProductCode><productCode>KDI</productCode><productCodeName>Dialyzer, High Permeability With Or Without Sealed Dialysate System</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="90"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="140"/><storageHandlingLow unit="Degrees Fahrenheit" value="-4"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Atmospheric Air Pressure between 500 and 1060 millibar, Relative Humidity is non-condensing.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>