<?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>3d59a891-9f87-4b86-aa84-4d9a95ad886d</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2019-07-23</publicVersionDate><devicePublishDate>2019-05-29</devicePublishDate><deviceCommDistributionEndDate>2019-07-12</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M752IM12645</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>M752IM12640</containsDINumber><pkgQuantity>6</pkgQuantity><pkgDiscontinueDate>2019-07-12</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>outer box</pkgType></identifier><identifier><deviceId>M752IM12640</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Stradis Medical, LLC</brandName><versionModelNumber>IM1264</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>043537671</dunsNumber><companyName>STRADIS MEDICAL LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Hazardous Drug Spill Kit</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>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>1-800-424-8520</phone><phoneExtension xsi:nil="true"/><email>CS@stradishealthcare.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>17415</gmdnCode><gmdnPTName>Cytotoxic material spill kit</gmdnPTName><gmdnPTDefinition>A set of devices used to clean up spillage of cytotoxic material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes/><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>