{"publicDeviceRecordKey":"0479ccd8-1686-42f5-a2ba-92bc5d1dda3d","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-08-24T00:00:00.000Z","devicePublishDate":"2023-08-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B005LF722050","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AincA®","versionModelNumber":"LF-722-05","catalogNumber":"LF-722-05","dunsNumber":"002065670","companyName":"ANESTHESIA ASSOCIATES, INC.","deviceCount":1,"deviceDescription":"Bag, Breathing, FLUTED, 22mmF Rubber Bushing, 0.5 Liter (500cc), Black Neoprene","DMExempt":true,"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":"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":[{"sizeType":"Total Volume","size":{"unit":"Liter","value":"0.5"},"sizeText":null,"sizeString":"Total Volume: 0.5 Liter"}]},"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":[]}}