<?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>5550acd1-aef7-4622-9b30-6caf1aa5004c</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-04-17</publicVersionDate><devicePublishDate>2015-09-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>35019315106952</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>Portex</brandName><versionModelNumber>100/544/000</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>118380146</dunsNumber><companyName>ICU MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription xsi:nil="true"/><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>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/><gmdnTerms><gmdn><gmdnCode>45623</gmdnCode><gmdnPTName>General-purpose non-vascular guidewire</gmdnPTName><gmdnPTDefinition>A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JOH</productCode><productCodeName>Tube tracheostomy and tube cuff</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>