<?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>08662683-8ebd-4a79-ac7f-82a878707bae</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2022-08-16</publicVersionDate><devicePublishDate>2021-09-30</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00810071632068</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>00810094571757</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00810071632068</containsDINumber><pkgQuantity>100</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>CS</pkgType></identifier></identifiers><brandName>Curaplex</brandName><versionModelNumber>670242-KIT</versionModelNumber><catalogNumber>670242-KIT</catalogNumber><dunsNumber>070556204</dunsNumber><companyName>BOUND TREE MEDICAL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Curaplex SAM IO 45mm Needle Kit</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</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>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>18009</gmdnCode><gmdnPTName>Intraosseous infusion kit</gmdnPTName><gmdnPTDefinition>A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone&apos;s medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>OKE</productCode><productCodeName>Port introducer kit</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>