<?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>d3af46ee-dc66-47a3-8168-ae4f2435fbb9</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-07-09</publicVersionDate><devicePublishDate>2025-07-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00810929018006</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00810929017993</containsDINumber><pkgQuantity>12</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>case</pkgType></identifier><identifier><deviceId>00810929017993</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>PREPZYME FOREVER WET (16.9oz/500ml with sprayer)</brandName><versionModelNumber>34577-16</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>082779828</dunsNumber><companyName>Ruhof Corporation</companyName><deviceCount>1</deviceCount><deviceDescription>Enzymatic detergents used to clean medical instruments.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</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/><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>FLG</productCode><productCodeName>Cleaner, Ultrasonic, Medical Instrument</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="130"/><storageHandlingLow unit="Degrees Fahrenheit" value="40"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="130"/><storageHandlingLow unit="Degrees Fahrenheit" value="40"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>