<?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>1ee5eb78-417a-47b9-a8fe-b0b7944b17ec</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2023-12-08</publicVersionDate><devicePublishDate>2023-11-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10841736123772</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><identifier><deviceId>10841736124007</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10841736123772</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier></identifiers><brandName>CleanStart</brandName><versionModelNumber>CSTART-9205</versionModelNumber><catalogNumber>CSTART-9205</catalogNumber><dunsNumber>078375583</dunsNumber><companyName>SKYTRON LLC</companyName><deviceCount>1</deviceCount><deviceDescription>CleanStart  Enzyme Detergent for Manual Wash Sinks 5 gal
</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>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts><customerContact><phone>+1(800) 759-8766</phone><phoneExtension xsi:nil="true"/><email>info@skytron.us</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>63385</gmdnCode><gmdnPTName>Medical device cleaning agent</gmdnPTName><gmdnPTDefinition>A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MEC</productCode><productCodeName>Disinfector, medical devices</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>