{"publicDeviceRecordKey":"5a6ff13b-c3d9-4cee-937e-3d50133b5021","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-07-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M996NSGC0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NS-GC Gauge Cover","versionModelNumber":"NS-GC","catalogNumber":"NS-GC","dunsNumber":"053146767","companyName":"INSTRUMENTATION INDUSTRIES, INCORPORATED","deviceCount":1,"deviceDescription":"The Instrumentation Industries, Inc. NS-GC Gauge Cover is an accessory to, and fits all, III NS-Series Vacuum/Pressure Gauges and NIF Meters.  Shock absorbent material helps prevent gauge and crystal breakage. ","DMExempt":false,"premarketExempt":false,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-412-854-1133","phoneExtension":null,"email":"raqa@iiimedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K081693","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46634","gmdnPTName":"Airway pressure monitor, non-powered","gmdnPTDefinition":"A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BXR","productCodeName":"Meter, Airway Pressure (Inspiratory Force)"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}