{"publicDeviceRecordKey":"8f9e1259-663f-4f73-9fec-f3e7f7c8ba39","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-02-19T00:00:00.000Z","devicePublishDate":"2026-02-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"38033178019119","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033178019118","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"08033178019118","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Ventricular Vent Catheter","versionModelNumber":"VT-84410","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":"K981601","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46363","gmdnPTName":"Chamber-decompression cardiac catheter","gmdnPTDefinition":"A thick plastic tube designed to decompress a heart chamber during a surgical procedure. It is typically used to decompress the left heart during cardiopulmonary bypass surgery, especially the left ventricle during aortic cross-clamping. It may include a pressure monitoring line to continuously measure the pressure of a chamber. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DWF","productCodeName":"Catheter, cannula and tubing, vascular, 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}