{"publicDeviceRecordKey":"5d70bfe3-ccc5-4a2c-b554-dd8700ccfdbd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M996RB0040","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"RB 004 Gauge Rail Clamp","versionModelNumber":"RB 004","catalogNumber":"RB 004","dunsNumber":"053146767","companyName":"INSTRUMENTATION INDUSTRIES, INCORPORATED","deviceCount":1,"deviceDescription":"The RB 004 Gauge Rail Clamp is an accessory to the NS Series Vacuum/Pressure Gauges.  The RB 004 is used to securely mount Gauges with a rear 1/4\" NPT thread to rails.  For use with Fairfield-style rails only.","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":"412-854-1133","phoneExtension":null,"email":"raqa@iiimedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K081778","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":"CAP","productCodeName":"Monitor, Airway Pressure (Includes Gauge And/Or Alarm)"}]},"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}