<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>9aaa2b21-7486-4912-98ee-8e54b5ee3567</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2021-03-01</publicVersionDate><devicePublishDate>2021-02-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03661540302008</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Nanoduct® Pos (+) Red Holder, Qty 1</brandName><versionModelNumber>RP-357</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>052423787</dunsNumber><companyName>ELITECHGROUP INC.</companyName><deviceCount>1</deviceCount><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.
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>1-800-453-2725</phone><phoneExtension xsi:nil="true"/><email>service_ebs@elitechgroup.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K010031</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>60355</gmdnCode><gmdnPTName>Sweat-induction iontophoresis device/conductivity analyser</gmdnPTName><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).</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KTB</productCode><productCodeName>Device, Iontophoresis, Specific Uses</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>