{"publicDeviceRecordKey":"3551b711-642d-4a15-acbc-127732dd5403","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-01-16T00:00:00.000Z","devicePublishDate":"2026-01-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M995995000241","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"M995995000243","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M995995000241","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null}]},"brandName":"Adaptive Cylindrical Cuff, Limited Reuse ","versionModelNumber":"9-9500-024","catalogNumber":null,"dunsNumber":"251078945","companyName":"Delfi Medical Innovations Inc","deviceCount":1,"deviceDescription":"Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper fit, and color coded for size identification. Each Delfi Adaptive Tourniquet Cuff includes a single use Matching Limb Protection Sleeve. \nDelfi Adaptive Tourniquet Cuffs are provided sterile, and may be reused in a non-sterile manner for up to five uses. Delfi Adaptive Tourniquet Cuffs are not designed to be resterilized. Dispose of properly after use\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+16047420600","phoneExtension":null,"email":"info@delfimedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35925","gmdnPTName":"Tourniquet cuff, single-use","gmdnPTDefinition":"A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KCY","productCodeName":"Tourniquet, Pneumatic"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}