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510(k) Data Aggregation
K Number
K983512Device Name
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
Manufacturer
Date Cleared
1999-04-28
(203 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
WATER VAULT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The WaterVault Cube Water Treatment System for HemoDialysis is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.
Device Description
Organic, inorganic and microbial contaminants are removed from water supplied to hemodialysis clinics for use in the dilution and preparation of dialysate solutions used in hemodialysis machines. The water treatment system includes a means of tempering the water and pretreatment, followed by reverse osmosis, ultrafiltration and UV sterilization. Pretreatment includes water softening to remove hardness and Granular Activated Carbon treatment to remove Chloramines in addition to filament cartridge filters to control particulate solids. Reverse Osmosis utilizes a pressure gradient to reverse the process water diffusion across a semipermeable membrane, concentrating the contaminants which are subsequently rejected as concentrate. Water forced through the membrane known as "Permeate" is then passed through a hollow fiber ultra filter to remove microorganisms, pyrogens and endotoxins. A UV light source that provides a minimum of 30,000 microwatts/cm2 sec limits further bacterial growth in the treated water.
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