{"publicDeviceRecordKey":"013bd926-8578-4a56-aa77-26aa281f20c0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-10-24T00:00:00.000Z","devicePublishDate":"2015-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"44710810100800","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"24710810100806","pkgQuantity":2,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton"},{"deviceId":"24710810100806","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"04710810100802","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"04710810100802","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Babi.Plus","versionModelNumber":"BC23-HD","catalogNumber":"12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port","dunsNumber":"656854379","companyName":"GALEMED CORPORATION","deviceCount":1,"deviceDescription":"Distributed by Teleflex","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K110383","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16803","gmdnPTName":"Ventilator IMV supplemental circuit, single-use","gmdnPTDefinition":"A device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of plastics and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BZD","productCodeName":"Ventilator, Non-Continuous (Respirator)"}]},"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}