{"publicDeviceRecordKey":"f72e4dc8-9268-4950-bc7b-136589699578","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-11-25T00:00:00.000Z","devicePublishDate":"2018-05-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04035324029747","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TRACOE silcosoft","versionModelNumber":"REF 371-3.0-C24","catalogNumber":"REF 371-3.0-C24","dunsNumber":"319414785","companyName":"Tracoe medical GmbH","deviceCount":1,"deviceDescription":"Tracheostomy Tube for Children","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+49613691690","phoneExtension":null,"email":"info@tracoe.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K172720","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35404","gmdnPTName":"Tracheostomy tube, non-reinforced, non-customized, single-use","gmdnPTDefinition":"A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JOH","productCodeName":"Tube Tracheostomy And Tube Cuff"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Lumen/Inner Diameter","size":{"unit":"Millimeter","value":"3.0"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 3.0 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize."},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"40"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"10"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}