{"publicDeviceRecordKey":"a59f09bc-4687-4aed-b92b-0bcdbdddfc11","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-07-17T00:00:00.000Z","devicePublishDate":"2024-07-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00848530040468","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CPAP Filter","versionModelNumber":"CS006PL","catalogNumber":null,"dunsNumber":"141668116","companyName":"SUNSET HEALTHCARE SOLUTIONS, INC.","deviceCount":1,"deviceDescription":"Premium Chinstrap","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"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":"8775786738","phoneExtension":null,"email":"customerservice@sunsethcs.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65874","gmdnPTName":"CPAP/BPAP chin strap, reusable","gmdnPTDefinition":"A non-latex device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) therapy using a nasal mask or cannula, to control mouth air leaks by gently holding the mouth closed. It is available in sizes appropriate for neonatal to adult patients. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BTK","productCodeName":"Strap, Head, Gas Mask"}]},"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":[]}}