Nephros, Inc. announced that its Dual Stage Ultrafilters (DSU) received 510(k) approval from US FDA. The DSU is used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.
The DSU is Nephros’s first FDA approved device in the US and represents an important milestone for the company, said Ernest Elgin, President and CEO of Nephros, Inc., within dialysis clinics, microbial and endotoxin contamination of the water and dialysate concentrate used to prepare dialysate is an ongoing concern. Nephros’s DSU filters are designed to eliminate these contaminants.
The Nephros DSU filters particles down to the 0.005-micron level and addresses dialysate contaminants at crucial points: after the reverse osmosis module and at the dialysis machine entrance from the water distribution loop. In the water purification process, the DSU filter can be used as the last step to ensure ultra pure water for dialysis procedures. When used with modern water treatment systems and optimally designed hemodialysis machines, the DSU filter offers an affordable safety measure.