{"publicDeviceRecordKey":"9d30be0e-9816-4583-b043-af2537796304","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2018-10-18T00:00:00.000Z","devicePublishDate":"2018-09-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M996KC50","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"KC 5 Pressure Adapter ","versionModelNumber":"KC 5","catalogNumber":"KC 5","dunsNumber":"053146767","companyName":"INSTRUMENTATION INDUSTRIES, INCORPORATED","deviceCount":1,"deviceDescription":"The KC 5 Pressure Adapter:  Dimensions - Luer Lock port  x 15mm I.D./22mm O.D. x  15mm O/D. ","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"412-854-1133","phoneExtension":null,"email":"raqa@iiimedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61621","gmdnPTName":"Breathing circuit pressure detection port plug","gmdnPTDefinition":"A non-sterile device designed to seal the port of a breathing circuit pressure detection adaptor/connector (e.g., Y-piece) when the port is not needed for pressure monitoring. It is typically a small Luer cap made of plastic (e.g., polysulphone). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BYX","productCodeName":"Tubing, Pressure And Accessories"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide","High-level Disinfectant"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}