{"publicDeviceRecordKey":"07da5a61-6793-49ed-ad56-b60c0c9f047b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2022-08-30T00:00:00.000Z","devicePublishDate":"2015-09-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EBES3510011","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Montgomery® Cannula Speaking Valve","versionModelNumber":"351001","catalogNumber":"351001","dunsNumber":"131855157","companyName":"Boston Medical Products, Inc.","deviceCount":1,"deviceDescription":"Size: 10; Type: Silicone","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":"K955516","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36071","gmdnPTName":"Tracheostomy tube speech valve","gmdnPTDefinition":"A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JOH","productCodeName":"Tube Tracheostomy And Tube Cuff"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Size: 10"}]},"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}