{"publicDeviceRecordKey":"e6bda812-0ba0-4157-9c57-40c2d3ed6edf","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-04-08T00:00:00.000Z","devicePublishDate":"2021-03-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B00500199TOP0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AincA®","versionModelNumber":"00-199-TOP","catalogNumber":"00-199-TOP","dunsNumber":"002065670","companyName":"ANESTHESIA ASSOCIATES, INC.","deviceCount":1,"deviceDescription":"Manometer, Pressure, -40 to +80 cm H2O, 1/4\" NPT-M Top-Mount, 2.5\"Dia, Front Zero-Adjust","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(760)744-6561","phoneExtension":null,"email":"Solutions@AincA.com"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}