<?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>5e56af94-c2b5-432c-85c8-2ca497dadcf5</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-02-16</publicVersionDate><devicePublishDate>2023-02-08</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>20609271069415</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00609271069411</containsDINumber><pkgQuantity>36</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>00609271069411</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>10609271069418</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00609271069411</containsDINumber><pkgQuantity>12</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Box</pkgType></identifier></identifiers><brandName>Cast boot, canvas</brandName><versionModelNumber>CBO4</versionModelNumber><catalogNumber>CBO4</catalogNumber><dunsNumber>184231298</dunsNumber><companyName>DARCO INTERNATIONAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Extra-large  Navy Open-toe</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>true</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/><gmdnTerms><gmdn><gmdnCode>10667</gmdnCode><gmdnPTName>Cast boot</gmdnPTName><gmdnPTDefinition>A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IPG</productCode><productCodeName>SHOE, CAST</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>