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The RenaPure filter is a bacterial and endotoxin retentive filter intended for use in a centralized loop as the final step of a water purification cascade to provide standard dialysis water to machine servicing multiple patients. This filter is not intended to service as the sole means of water purification and therefore must be used in conjunction with other water treatment equipment.

The RenaPure filter is a 20" cartridge style filter in a polypropylene casing that contains dual-layered, 0.22 micron polyethersulfone (PES) pleated membranes which are separated by polypropylene screen layers. The PES membrane is charge modified with a positive charge coating, similar to the predicate device, that aids in removal of endotoxin by charge attraction. Filter configurations are based on an industry standard 222 header design with silicone O-rings at the open end of the filter and flat or fin end caps at the closed end. The filter cartridge is installed in a durable filter housing and operates in a dead-end mode. The filter is designed to remove bacteria and endotoxin from water used in hemodialysis with similar water flow characteristics as the predicate device. The filter provided non-sterile.