{"publicDeviceRecordKey":"6cf0b19d-4fa2-4800-988a-72544f0f0f36","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-08-28T00:00:00.000Z","devicePublishDate":"2025-08-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"06976110830360","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TOMORE","versionModelNumber":"5128L(TE)","catalogNumber":null,"dunsNumber":"699487204","companyName":"Tomore Medical (Shenzhen) Co., Ltd","deviceCount":1,"deviceDescription":"Hearing Aid","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62260","gmdnPTName":"Air-conduction hearing aid acoustic tube","gmdnPTDefinition":"A small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ESD","productCodeName":"Hearing Aid, Air-Conduction, Prescription"}]},"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":[]}}