{"publicDeviceRecordKey":"2f58cca8-9651-4a21-a3e4-32f905f7f028","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2022-08-30T00:00:00.000Z","devicePublishDate":"2015-09-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EBES3106060","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Plug/Ring Set","versionModelNumber":"310606","catalogNumber":"310606","dunsNumber":"131855157","companyName":"Boston Medical Products, Inc.","deviceCount":1,"deviceDescription":"Size: 6","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 Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-433-2674","phoneExtension":null,"email":"info@bosmed.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K802916","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47119","gmdnPTName":"Tracheostomy tube decannulation cap","gmdnPTDefinition":"A device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy identification, that is placed on the proximal end of a fenestrated or uncuffed tracheostomy tube to close the tracheostomy termination. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BTO","productCodeName":"Tube, Tracheostomy (W/Wo Connector)"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Size: 6"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from sunlight"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry"}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}