<?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>c89936f3-2b20-4286-bd53-7d81d5bccd2d</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-04-17</publicVersionDate><devicePublishDate>2016-06-30</devicePublishDate><deviceCommDistributionEndDate>2025-04-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00840682108423</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00840682108317</containsDINumber><pkgQuantity>20</pkgQuantity><pkgDiscontinueDate>2025-04-01</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>00840682108317</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>CLASSIC-CUF</brandName><versionModelNumber>CLA-T1-2A-X</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>784985108</dunsNumber><companyName>GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>CLASSIC-CUF ISO, THIGH, DINACLICK, 38 - 50 CM, SINGLE</deviceDescription><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>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>true</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)558-5120</phone><phoneExtension xsi:nil="true"/><email>xx@xx.xx</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K120125</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>37326</gmdnCode><gmdnPTName>Blood pressure cuff, single-use</gmdnPTName><gmdnPTDefinition>A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient&apos;s blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DXQ</productCode><productCodeName>blood pressure cuff</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Thigh</sizeText></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="95"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="15"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="55"/><storageHandlingLow unit="Degrees Celsius" value="-20"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>