{"publicDeviceRecordKey":"b2dbf4a2-29b3-49d8-b1e6-f53a24967603","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-02-02T00:00:00.000Z","devicePublishDate":"2026-01-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"09420012479136","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"09420012479129","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"PACK"},{"deviceId":"09420012479129","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"F\u0026P OptiPAP Junior","versionModelNumber":"OPTIPAPC2330","catalogNumber":"OPTIPAPC2330","dunsNumber":"590153276","companyName":"FISHER \u0026 PAYKEL HEALTHCARE LIMITED","deviceCount":1,"deviceDescription":"OptiPAP Junior Chinstrap 23-30cm\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1800 446 3908","phoneExtension":null,"email":"Customer.CareUSA@fphcare.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65873","gmdnPTName":"CPAP/BPAP chin strap, single-use","gmdnPTDefinition":"A non-latex device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) therapy using a nasal mask or cannula, to control mouth air leaks by gently holding the mouth closed. It is available in sizes appropriate for neonatal/infant to adult patients. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BZO","productCodeName":"Set, Tubing And Support, Ventilator (W Harness)"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"17-24CM"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"50"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"122"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"14"},"storageHandlingSpecialConditionText":null}]},"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":[]}}