{"publicDeviceRecordKey":"4966f2ae-7c64-4e90-a60f-167aa5c2ca4a","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2026-03-19T00:00:00.000Z","devicePublishDate":"2014-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"09321502012201","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Nucleus","versionModelNumber":"Z145928","catalogNumber":"Z145928","dunsNumber":"750551194","companyName":"COCHLEAR LIMITED","deviceCount":1,"deviceDescription":"NUCLEUS FREEDOM N22 COIL, 6CM,BLK","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"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(800)523-5798","phoneExtension":null,"email":"customer@cochlear.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"P970051","supplementNumber":"028"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58184","gmdnPTName":"Cochlear implant/auditory brainstem implant external coil","gmdnPTDefinition":"An external component of a cochlear implant (CI) or auditory brainstem implant system designed to transmit the electrical signals generated by the sound processor to the implantable receiver-stimulator and electrode array assembly (none included) of the hearing implant for the partial restoration of auditory sensation in a severely/profoundly deaf person. It is typically a round-shaped device with a magnet in its centre to magnetically couple with the implantable receiver-stimulator.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MCM","productCodeName":"IMPLANT, COCHLEAR"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"6cm long coil"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"6"},"sizeText":null,"sizeString":"Length: 6 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"0"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"50"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-20"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"0"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"50"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-20"},"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}