{"publicDeviceRecordKey":"75a31da4-0c99-4937-9f04-d400414c5163","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2018-03-29T00:00:00.000Z","devicePublishDate":"2015-06-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"37332414106936","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MARS Monitor ","versionModelNumber":"800437","catalogNumber":"800437","dunsNumber":"354021099","companyName":"GAMBRO AB","deviceCount":1,"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. \n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)933-0303","phoneExtension":null,"email":"medinfo_medproducts@baxter.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46214","gmdnPTName":"Bound solute dialysis system pump/monitor","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'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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FLD","productCodeName":"Apparatus, Hemoperfusion, Sorbent"},{"productCode":"KDI","productCodeName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"140"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"-4"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Atmospheric Air Pressure between 500 and 1060 millibar, Relative Humidity is non-condensing."}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}