<?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>36e1b0fc-6134-4bd1-8453-0a3694a62ddb</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2019-12-11</publicVersionDate><devicePublishDate>2017-04-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M996KC0180</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>KC 018 - 22mm ID Reusable Ventilator Tubing</brandName><versionModelNumber>KC 018</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>053146767</dunsNumber><companyName>INSTRUMENTATION INDUSTRIES, INCORPORATED</companyName><deviceCount>1</deviceCount><deviceDescription>KC 018,  22mm ID, 18&quot; length - Reusable Ventilator Tubing - polyester elastomer tube with silicone rubber cuffs </deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts><customerContact><phone>412-854-1133</phone><phoneExtension xsi:nil="true"/><email>raqa@iiimedical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>37705</gmdnCode><gmdnPTName>Ventilator breathing circuit, reusable</gmdnPTName><gmdnPTDefinition>An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>BZO</productCode><productCodeName>Set, Tubing And Support, Ventilator (W Harness)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod><sterilizationMethod>Ethylene Oxide</sterilizationMethod><sterilizationMethod>Liquid Chemical</sterilizationMethod></methodTypes></sterilization></device>