{"publicDeviceRecordKey":"9aaa2b21-7486-4912-98ee-8e54b5ee3567","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-03-01T00:00:00.000Z","devicePublishDate":"2021-02-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03661540302008","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Nanoduct® Pos (+) Red Holder, Qty 1","versionModelNumber":"RP-357","catalogNumber":null,"dunsNumber":"052423787","companyName":"ELITECHGROUP INC.","deviceCount":1,"deviceDescription":"For use with Neonatal Sweat Analysis System to attach electrodes and sensor cells used to induce and collect sweat for diagnosis of Cystic Fibrosis.\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-453-2725","phoneExtension":null,"email":"service_ebs@elitechgroup.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K010031","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60355","gmdnPTName":"Sweat-induction iontophoresis device/conductivity analyser","gmdnPTDefinition":"A portable, battery-powered electronic device intended to induce sweating by the transdermal introduction of a water-soluble electrolytic substance (i.e., pilocarpine) into the sweat glands using an electric stimulus (iontophoresis), and subsequently measure the electrical conductivity of the sweat using a continuous flow cell; thus providing an indication of the total electrolyte concentration. It typically consists of a portable conductivity analyser that contacts the patient via microelectrodes embedded in a non-conductive sensor held against the stimulated skin. The device is used to help diagnose cystic fibrosis (CF).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KTB","productCodeName":"Device, Iontophoresis, Specific Uses"}]},"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}