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FDA clears Mar Cor Purification's BioPure HX2 water treatment system
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Mar Cor Purification, a subsidiary of Cantel Medical has been given 510(k) clearance from the U.S. Food and Drug Administration for the BioPure HX2, a heat disinfectable central reverse osmosis (RO) water system for dialysis. The BioPure HX2 is a Double Pass RO with automatic hot water disinfection with four different modes. Mar Cor had previously been awarded a Class 3 Device License from Health Canada in 2013 for the system, which has been available in the Canadian and international markets for more than a year.
The system is designed to produce high quality water and distribution for large capacity applications up to 50 stations and/or 1,000 foot loop lengths. An added feature to the design is the ability to operate either as a double pass RO or as a single RO in the event of any issues with either pass. In order to reduce the carbon footprint of the system, the system is outfitted with VFD drives and automatic adjustment of product flow and reject flow based on demand and feed water quality, conserving water and energy. The system will be manufactured in the Mar Cor factory in Burlington, Ontario, Canada.
“The BioPure HX2 is a next generation, state of the art RO and Distribution system that will meet and exceed the stringent requirements for dialysis and hemodiafiltration water treatment anywhere in the world," said John Rickert, VP of medical sales at Mar Cor.