{"publicDeviceRecordKey":"6d0aa17b-1e25-4809-b86b-7119ca339d86","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-01-09T00:00:00.000Z","devicePublishDate":"2022-12-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00810071638053","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00810071637360","pkgQuantity":50,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"00810071637360","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Curaplex","versionModelNumber":"2201","catalogNumber":"87-2201","dunsNumber":"070556204","companyName":"BOUND TREE MEDICAL, LLC","deviceCount":1,"deviceDescription":"Curaplex Oxygen Mask, Pediatric, High Conc, Partial NRB, 7 ft Tubing, Disp 50/cs","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35172","gmdnPTName":"Aerosol face mask, non-rebreathing","gmdnPTDefinition":"A flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KGB","productCodeName":"MASK, OXYGEN, NON-REBREATHING"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"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":[]}}