{"publicDeviceRecordKey":"cd2f8b0f-0a73-477c-b3f1-ce3e10b95bdb","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":"B005E1200","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AincA®","versionModelNumber":"E-120","catalogNumber":"E-120","dunsNumber":"002065670","companyName":"ANESTHESIA ASSOCIATES, INC.","deviceCount":1,"deviceDescription":"Bag, Breathing, FLAT, Kuhn (w/Thumb Hole Vent), 22mmF Rubber Bushing, 500cc, Black Latex","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(760)744-6561","phoneExtension":null,"email":"Solutions@AincA.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37709","gmdnPTName":"Breathing circuit bag, reusable","gmdnPTDefinition":"A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BTC","productCodeName":"BAG, RESERVOIR"}]},"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":[]}}