<?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>f5d81fc9-9d6c-43aa-afc7-56826a9faabf</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-09-12</publicVersionDate><devicePublishDate>2022-09-02</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>14719882250801</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>04719882250804</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Carton</pkgType></identifier><identifier><deviceId>04719882250804</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>04719882250798</deviceId><deviceIdType>Unit of Use</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>Copioumed</brandName><versionModelNumber>SSN0B101-1</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>658318113</dunsNumber><companyName>COPIOUMED INTERNATIONAL INC.</companyName><deviceCount>10</deviceCount><deviceDescription>Copioumed’s scrub suits are protective outfits made for medical personnel for use in operating rooms when they might come in touch with an infectious substance or body fluid. </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>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+886227721815</phone><phoneExtension xsi:nil="true"/><email>info@gcv.com.tw</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>58382</gmdnCode><gmdnPTName>Scrub suit, single-use</gmdnPTName><gmdnPTDefinition>A two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FXO</productCode><productCodeName>Suit, Surgical</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>