{"publicDeviceRecordKey":"07fe18cd-9035-4d76-8210-19fee96d2c2b","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-01-26T00:00:00.000Z","devicePublishDate":"2026-01-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"38033178113152","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033178113151","pkgQuantity":2,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"BOX"},{"deviceId":"08033178113151","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"INSPIRE","versionModelNumber":"HCR","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":true,"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":"K251783","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31710","gmdnPTName":"Cardiotomy reservoir","gmdnPTDefinition":"A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DTN","productCodeName":"Reservoir, blood, cardiopulmonary bypass"}]},"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}