<?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>74914d81-0d8b-44fa-bbcc-abb64df7d596</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2023-08-08</publicVersionDate><devicePublishDate>2016-09-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>56927675503973</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>36927675503979</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Carton</pkgType></identifier><identifier><deviceId>36927675503979</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>06927675503978</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>SURSHIELD</brandName><versionModelNumber>SV*S25BL</versionModelNumber><catalogNumber>SV*S25BL</catalogNumber><dunsNumber>544830912</dunsNumber><companyName>Terumo Medical Products (Hangzhou) Co., Ltd.</companyName><deviceCount>50</deviceCount><deviceDescription>SURSHIELD Safety Winged Infusion Set</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</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>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)283-7866</phone><phoneExtension xsi:nil="true"/><email>tmccustomer.admin@terumomedical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>65416</gmdnCode><gmdnPTName>Basic intravenous administration set, invasive</gmdnPTName><gmdnPTDefinition>A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient&apos;s venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FPA</productCode><productCodeName>Set, administration, intravascular</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="0.4"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Needle Gauge</sizeType><size unit="Gauge" value="25"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="0.75"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Tubing Length:12inch</sizeText></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Type: Thin Wall (TW)</sizeText></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Do not store at extreme temperature and humidity. Keep away from sunlight. Stacking limit by 5.Fragile, handle with care.Keep dry.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>