<?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>a28eea26-95aa-41a1-a5ec-2f2c1a23bd0d</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-11-19</publicVersionDate><devicePublishDate>2019-02-03</devicePublishDate><deviceCommDistributionEndDate>2024-11-14</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>20763000200071</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00763000200077</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate>2024-11-14</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>PK</pkgType></identifier><identifier><deviceId>00763000200077</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></identifiers><brandName>Goodale-Lubin™</brandName><versionModelNumber>990106</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>006261481</dunsNumber><companyName>MEDTRONIC, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>WVN CATH 990106 10PK 6F 125CM GOODLE LB</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>false</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>+1(800)633-8766</phone><phoneExtension xsi:nil="true"/><email>Corporate.UDI@medtronic.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>10688</gmdnCode><gmdnPTName>Angiographic catheter, single-use</gmdnPTName><gmdnPTDefinition>A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DQO</productCode><productCodeName>CATHETER, INTRAVASCULAR, DIAGNOSTIC</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Lumen/Inner Diameter</sizeType><size unit="Millimeter" value="0.965"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="125.0"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Catheter Gauge</sizeType><size unit="French" value="6.0"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Store catheters in a cool, dry area.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>