{"publicDeviceRecordKey":"d76e1600-8c03-4efd-94c3-326aba2d0c3c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-01-14T00:00:00.000Z","devicePublishDate":"2018-12-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B718DL82030","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Multiplace Hyperbaric Oxygen Treatment Chamber","versionModelNumber":"DL8","catalogNumber":"DL8203","dunsNumber":"748668373","companyName":"FINK ENGINEERING PTY LTD","deviceCount":1,"deviceDescription":"A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+61754384900","phoneExtension":null,"email":"support@fink.com.au"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K031649","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"12061","gmdnPTName":"Hyperbaric chamber, stationary","gmdnPTDefinition":"A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"CBF","productCodeName":"Chamber, Hyperbaric"}]},"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}