{"publicDeviceRecordKey":"9566abd6-b6f0-4202-9a18-b9601bd964c6","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2020-01-30T00:00:00.000Z","devicePublishDate":"2018-11-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"14026704390141","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"34026704390145","pkgQuantity":50,"pkgDiscontinueDate":"2019-09-30","pkgStatus":"Not in Commercial Distribution","pkgType":"Case"},{"deviceId":"34026704390145","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"HUDSON RCI","versionModelNumber":"IPN044433","catalogNumber":"41635","dunsNumber":"002348191","companyName":"TELEFLEX INCORPORATED","deviceCount":1,"deviceDescription":"DISPOSABLE THERMOMETER,INTL","DMExempt":true,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(919)544-8000","phoneExtension":null,"email":"CS@TELEFLEX.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60658","gmdnPTName":"Respiratory gas thermometer","gmdnPTDefinition":"A non-sterile device intended to measure the temperature of respiratory gases prior to entering a patient’s airway to help manage patient comfort and facilitate therapeutic compliance. It is a slender, hollow glass tube with a bulb at the base that is filled with coloured alcohol whereby temperature is measured based on the capillary principle. It is intended to be inserted into a compatible temperature monitor port of a breathing circuit connecter (e.g., Y-piece connecter); it may be used in the home or healthcare facility. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FQZ","productCodeName":"THERMOMETER, CLINICAL COLOR CHANGE"}]},"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":[]}}