{"publicDeviceRecordKey":"df83be25-7d4e-4222-beb8-221436960f2c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-09-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B036100657","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SleepWeaver Elan - Mask Only - Regular - Leopard","versionModelNumber":"100657","catalogNumber":"100657","dunsNumber":"012721295","companyName":"CIRCADIANCE, LLC","deviceCount":1,"deviceDescription":"SleepWeaver Elan Cloth Nasal PAP Mask Only - Regular - Leopard","DMExempt":false,"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":"1-888-825-9640","phoneExtension":null,"email":"info@circadiance.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K120757","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"57815","gmdnPTName":"CPAP/BPAP nasal mask, reusable","gmdnPTDefinition":"A flexible, form-shaped device designed to be placed over a user's nose 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 and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BZD","productCodeName":"Ventilator, Non-Continuous (Respirator)"}]},"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}