{"publicDeviceRecordKey":"199f44fe-308f-4ae7-9741-91a2b240ba48","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-10-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"MP0001","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MEDIPAC, 2880GPD, DIRECT FEED, 115V","versionModelNumber":"EQMEDIPAC-2880-DF-10","catalogNumber":"EQMEDIPAC-2880-DF-10","dunsNumber":"055252159","companyName":"BETTER WATER, LLC","deviceCount":1,"deviceDescription":"Complete water purification system on a single platform with casters for dialysis applications.  Direct-feed, 2880 gallons per day, 115V.  Includes the following components:\n- Pretreatment: carbon media tanks (carbon \u0026 polisher), water softener (tank and brine tank), particulate filtration, and UV light.\n- Reverse Osmosis device: 1232 series\n- Posttreatment: particulate filtration, and UV light\n- Other: disinfect tank","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K920186","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44344","gmdnPTName":"Combination water purification system","gmdnPTDefinition":"An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FIP","productCodeName":"Subsystem, Water Purification"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}