{"publicDeviceRecordKey":"4bd8c1e4-7fa4-4b79-8588-a853c000ebca","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-07-10T00:00:00.000Z","devicePublishDate":"2025-07-02T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10848530106345","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00848530106348","pkgQuantity":50,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"00848530106348","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Tracheostomy and Suction Accessory","versionModelNumber":"VEN004","catalogNumber":null,"dunsNumber":"141668116","companyName":"SUNSET HEALTHCARE SOLUTIONS, INC.","deviceCount":1,"deviceDescription":"Active Exhalation Vlave Adapter with Pressure Tubing\nComparable OEM# 1065659\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"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":"62966","gmdnPTName":"Artificial airway cuff inflation tubing","gmdnPTDefinition":"A length of flexible tube designed to connect cuff inflation devices to deliver air during inflation of the cuff of an endotracheal (ET)/ tracheostomy tube. It typically includes connectors at each end. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BZA","productCodeName":"Connector, Airway (Extension)"}]},"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":[]}}