{"publicDeviceRecordKey":"81c5f7dd-3446-4e1e-8469-4815e7792d3a","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-01-11T00:00:00.000Z","devicePublishDate":"2023-01-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D678AS50C1","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"D678AS50C0","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"D678AS50C0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AirStar","versionModelNumber":"AS50C","catalogNumber":null,"dunsNumber":"043835081","companyName":"AIR TECHNIQUES, INC.","deviceCount":1,"deviceDescription":"AirStar® Dental Air Systems (AirStar®, AirStar® Monitor \u0026 AirStar® ECO) generate 100% oil-free, dry air which protects valuable hand pieces from premature failure due to the effects of moist air and the build-up of oil residue. Because no oil is used for mechanical lubrication, there is no chance of introducing an oily film to a prepared surface which could compromise resin retention and restorations, wasting chair time. Most important, patient’s health is protected with dry air that provides an environment that is not conducive to bacterial growth.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1 (516) 214-5512","phoneExtension":null,"email":"mardonio.nicolas@airtechniques.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31253","gmdnPTName":"Medical device air compressor","gmdnPTDefinition":"A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NRD","productCodeName":"Unit, Operative Dental, Accessories"}]},"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":[]}}