{"publicDeviceRecordKey":"f62aa899-553a-4eee-8cde-524898843dad","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-11-09T00:00:00.000Z","devicePublishDate":"2022-11-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10850043061066","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850043061069","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00850043061069","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"30850043061060","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10850043061066","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"}]},"brandName":"Dr Zee","versionModelNumber":"8015","catalogNumber":"8015","dunsNumber":"104305239","companyName":"Resp Devices LLC","deviceCount":1,"deviceDescription":"Tracheostomy Tube Holders. Two-Piece Wick Foam Collar with Hook and Loop Closure, Neonatal/Infant, 10/bx","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"917-299-1512","phoneExtension":null,"email":"respdevices@gmail.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63438","gmdnPTName":"Tracheostomy tube neck holder, single-use","gmdnPTDefinition":"A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"CBH","productCodeName":"Device, Fixation, Tracheal Tube"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Neonatal/infant. 3/4\" Wide, Max neck size 9\"/23cm"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry. Keep away from sunlight."}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}