<?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>a82ddd66-64f2-457b-8478-49bcb16458d1</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-08-21</publicVersionDate><devicePublishDate>2023-08-11</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07908398200220</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>Braincare</brandName><versionModelNumber>BcAc-AF-1000</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>903226227</dunsNumber><companyName>BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA</companyName><deviceCount>1</deviceCount><deviceDescription>Headband 1 of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000)</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Safe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1 (424) 888-2942</phone><phoneExtension xsi:nil="true"/><email>support@brain4.care</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K201989</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>16763</gmdnCode><gmdnPTName>Intracranial pressure monitor</gmdnPTName><gmdnPTDefinition>An electrically-powered device intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device (e.g., intracerebral sensor catheter) that transmits electrical signals via connected cables or pressure signals via tubing (e.g., via the air pouch method), or either telemetrically. It may include an alarm designed to alert clinical staff to an elevated ICP and may also produce a strip-chart recording or display of the ICP waveform that enables interpretation of long-term ICP trends.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GWM</productCode><productCodeName>Device, Monitoring, Intracranial Pressure</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="460"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="20"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="85"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="15"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="45"/><storageHandlingLow unit="Degrees Celsius" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>