{"publicDeviceRecordKey":"02356bdd-d661-4a96-9c9c-2fd8d34f3486","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2025-01-10T00:00:00.000Z","devicePublishDate":"2017-08-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04035479140755","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"BIOTRONIK","versionModelNumber":"BS IS4","catalogNumber":"403725","dunsNumber":"315620229","companyName":"BIOTRONIK SE \u0026 Co. KG","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(888)345-0374","phoneExtension":null,"email":"jon.brumbaugh@biotronik.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44900","gmdnPTName":"Implantable pulse generator port plug","gmdnPTDefinition":"A non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials; disposable devices intended to facilitate connection/stabilisation (e.g., torque wrench) may be included with the port plug.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NIK","productCodeName":"Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}