<?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>ad6e722f-cd06-460f-ba74-35cb1ad26832</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-10-13</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>RO0206</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>2436RO, 12600GPD, 208V, 7MEM</brandName><versionModelNumber>EQRMA-2412K-3L</versionModelNumber><catalogNumber>EQRMA-2412K-3L</catalogNumber><dunsNumber>055252159</dunsNumber><companyName>BETTER WATER, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Reverse osmosis device for water purification for dialysis applications. 2436 series, seven membranes, 208V.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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>K920186</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>14437</gmdnCode><gmdnPTName>Reverse-osmosis water purification system</gmdnPTName><gmdnPTDefinition>An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FIP</productCode><productCodeName>Subsystem, Water Purification</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>