{"publicDeviceRecordKey":"0b804805-da0f-4293-9912-3e94c04163be","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-10-14T00:00:00.000Z","devicePublishDate":"2015-11-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"40606959008562","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00606959008564","pkgQuantity":20,"pkgDiscontinueDate":"1999-12-31","pkgStatus":"Not in Commercial Distribution","pkgType":"PACK_OR_INNER_PACK"},{"deviceId":"00606959008564","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"30606959008565","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00606959008564","pkgQuantity":10,"pkgDiscontinueDate":"1999-12-31","pkgStatus":"Not in Commercial Distribution","pkgType":"PACK_OR_INNER_PACK"}]},"brandName":"AF421","versionModelNumber":"AF421 Mask with Entrainment Elbow, Leak 2, Large, Global","catalogNumber":"1119057","dunsNumber":"080728314","companyName":"Respironics, Inc.","deviceCount":1,"deviceDescription":"AF421 Mask with Entrainment Elbow, Leak 2, Global, Large\n","DMExempt":true,"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":"+1(724)744-2500","phoneExtension":null,"email":"respironics.service@philips.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"57813","gmdnPTName":"CPAP/BPAP face mask, single-use","gmdnPTDefinition":"A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BZD","productCodeName":"VENTILATOR, NON-CONTINUOUS (RESPIRATOR)"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"95"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"15"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"140"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"-4"},"storageHandlingSpecialConditionText":null}]},"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":[]}}