{"publicDeviceRecordKey":"5da463d0-8ab1-4743-b08d-6391df1c4f56","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-11-16T00:00:00.000Z","devicePublishDate":"2017-10-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10680651472011","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Halyard","versionModelNumber":"47201","catalogNumber":"20-0950","dunsNumber":"079375431","companyName":"Avanos Medical, Inc.","deviceCount":1,"deviceDescription":"HALYARD CORTRAK 2 Enteral Access System","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(847)403-3400","phoneExtension":null,"email":"questions@corpak.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"59078","gmdnPTName":"Enteral tube tracking system","gmdnPTDefinition":"A mains electricity (AC-powered) portable electronic device assembly, typically with rechargeable battery, designed to detect, record, and display an electromagnetic (EM) signal emitted from a transmitter in an enteral feeding tube stylet to facilitate the placement of the enteral tube, by providing a graphic display representing the path of the tube tip. It consists of an electromagnetic receiver placed on the epigastrium, a visual display/control unit which displays real-time anterior and cross-sectional representational views of the transmitter location and track, and a separately supplied single-use enteral feeding tube stylet which incorporates an electromagnetic transmitter in the tip.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KNT","productCodeName":"TUBES, GASTROINTESTINAL (AND ACCESSORIES)"}]},"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":[]}}