<?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>04c6706d-9083-41e6-b969-5032afdbf334</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2018-12-24</publicVersionDate><devicePublishDate>2018-11-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>70616258010655</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00616258010656</containsDINumber><pkgQuantity>600</pkgQuantity><pkgDiscontinueDate>9999-12-31</pkgDiscontinueDate><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>00616258010656</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>50616258010651</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00616258010656</containsDINumber><pkgQuantity>20</pkgQuantity><pkgDiscontinueDate>9999-12-31</pkgDiscontinueDate><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>40616258010654</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00616258010656</containsDINumber><pkgQuantity>20</pkgQuantity><pkgDiscontinueDate>9999-12-31</pkgDiscontinueDate><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier></identifiers><brandName>MEDRAD® Stellant FLEX Syringe Kit </brandName><versionModelNumber>FLEXD-150-SPK </versionModelNumber><catalogNumber>FLEXD-150-SPK </catalogNumber><dunsNumber>058716649</dunsNumber><companyName>BAYER MEDICAL CARE INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Stellant Dual 150mL Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (STLNT,KIT,SYR,CT,D,SPK,FLS3,150ML,RW) (85020218) 
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</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)633-7231</phone><phoneExtension xsi:nil="true"/><email>ricustomercomplaints@bayer.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K173773</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>15286</gmdnCode><gmdnPTName>Angiographic syringe</gmdnPTName><gmdnPTDefinition>A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IZQ</productCode><productCodeName>Injector, Contrast Medium, Automatic</productCodeName></fdaProductCode><fdaProductCode><productCode>DXT</productCode><productCodeName>Injector And Syringe, Angiographic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>