{"publicDeviceRecordKey":"49ac362a-fc73-47d0-be5d-2061ea894402","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2026-06-22T00:00:00.000Z","devicePublishDate":"2015-07-15T00:00:00.000Z","deviceCommDistributionEndDate":"2026-06-15T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"38033178105560","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"18033178105566","pkgQuantity":50,"pkgDiscontinueDate":"2026-06-15","pkgStatus":"Not in Commercial Distribution","pkgType":"BOX"},{"deviceId":"18033178105566","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033178105569","pkgQuantity":10,"pkgDiscontinueDate":"2026-06-15","pkgStatus":"Not in Commercial Distribution","pkgType":"BOX"},{"deviceId":"08033178105569","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AUTOTRANSFUSION ACCESSORIES","versionModelNumber":"BT277 (BRB1)","catalogNumber":null,"dunsNumber":"442126587","companyName":"SORIN GROUP ITALIA SRL","deviceCount":1,"deviceDescription":null,"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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K872162","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17605","gmdnPTName":"Autotransfusion system blood component processing set","gmdnPTDefinition":"A collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets) in conjunction with a dedicated pump (not included) as part of an autotransfusion procedure; it is not dedicated to suction and/or anticoagulation. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"CAC","productCodeName":"APPARATUS, AUTOTRANSFUSION"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}