<?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>953aa7f9-1024-4596-871f-0371c634524a</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-09-01</publicVersionDate><devicePublishDate>2025-08-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M689WJBBCPLUS1RF040</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>Bleeding Control Kit Plus Refill 6  </brandName><versionModelNumber>04</versionModelNumber><catalogNumber>WJBBCPLUS1RF.00</catalogNumber><dunsNumber>118492643</dunsNumber><companyName>Safeguard US Operating, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>The Bleeding Control Kit Plus Refill 6 is apart of the Public Access Trauma Kits are vacuum sealed kits that include instructions and interventions to address immediate threats to life from massive hemorrhage, airway compromise, respiratory, lacerations and hypothermia. </deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</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>true</rx><otc>false</otc><contacts><customerContact><phone>855-428-6074</phone><phoneExtension xsi:nil="true"/><email>fulfillment@combatmedical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44047</gmdnCode><gmdnPTName>First aid kit, non-medicated, single-use</gmdnPTName><gmdnPTDefinition>A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>OHO</productCode><productCodeName>First Aid Kit Without Drug</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>