{"publicDeviceRecordKey":"bda9603a-6066-46ad-88a2-fef1a1a4b403","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2021-04-23T00:00:00.000Z","devicePublishDate":"2016-08-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046963926304","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"04046963926298","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"xevonta","versionModelNumber":"7204405","catalogNumber":"7204405","dunsNumber":"343689704","companyName":"B.Braun Avitum AG","deviceCount":20,"deviceDescription":"XEVONTA DIALYZER HI 23 US, GAMMA","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)227-2862","phoneExtension":null,"email":"BBMUS_Service.EmailOrders@bbraun.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47072","gmdnPTName":"Hollow-fibre haemodialysis dialyser, single-use","gmdnPTDefinition":"A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KDI","productCodeName":"Dialyzer, high permeability with or without sealed dialysate system"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Max TMP (kPa) : 80.000 KPA"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Max TMP (mmHg) : 600.000 MHG"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Surface (m²) : 2.300 M2"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"0"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}