{"publicDeviceRecordKey":"36e1b0fc-6134-4bd1-8453-0a3694a62ddb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-12-11T00:00:00.000Z","devicePublishDate":"2017-04-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M996KC0180","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"KC 018 - 22mm ID Reusable Ventilator Tubing","versionModelNumber":"KC 018","catalogNumber":null,"dunsNumber":"053146767","companyName":"INSTRUMENTATION INDUSTRIES, INCORPORATED","deviceCount":1,"deviceDescription":"KC 018,  22mm ID, 18\" length - Reusable Ventilator Tubing - polyester elastomer tube with silicone rubber cuffs ","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":"37705","gmdnPTName":"Ventilator breathing circuit, reusable","gmdnPTDefinition":"An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BZO","productCodeName":"Set, Tubing And Support, Ventilator (W Harness)"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization","Ethylene Oxide","Liquid Chemical"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}