<?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>256c4fe6-b902-4e62-9151-949ba69cdda9</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2019-11-28</publicVersionDate><devicePublishDate>2016-09-09</devicePublishDate><deviceCommDistributionEndDate>2019-11-27</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>17350025911066</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>07350025911069</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate>2019-11-27</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>07350025911069</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>Follicle Aspiration Set, Single Lumen</brandName><versionModelNumber>14107</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>631805488</dunsNumber><companyName>Vitrolife Sweden AB</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>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/><premarketSubmissions><premarketSubmission><submissionNumber>K991273</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>45676</gmdnCode><gmdnPTName>IVF oocyte aspiration needle, single-use</gmdnPTName><gmdnPTDefinition>A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MQE</productCode><productCodeName>Needle, Assisted Reproduction</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>