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The Clearum™ HS 17 is intended for use in acute or chronic renal failure patients requiring hemodialysis

The Clearum™ HS 17 dialyzer is consisting of a cylindrical polypropylene body containing a bundle of microporous hollow fibers made of polyethersulfone (PES) secured to the ends by means of hot-melt polyurethane resin. The modifed Clearum™ HS 17 dialyzer is substantially equivalent to the predicate Clearum™ HS 17 dialyzer manufactured by Bellco (K193542, cleared on October 8, 2020). The device is characterized by a membrane surface area equivalent to 1.7 m², and by an outer housing total height of 306 mm and a maximum outside diameter of 44 mm. ldentical to the predicate Clearum™ HS 17, blood and dialysate flow in a countercurrent in their respective compartments. In this process, toxins and fluid are transferred across the semipermeable membrane from the blood to the dialysate compartment. The dialyzers are sterilized using moist heat with saturated steam, have a non-pyrogenic fluid path, and are labeled for single use.

The Clearum™ HS dialyzer family is intended for use in acute or chronic renal failure patients requiring hemodialysis.

The Clearum™ HS family consists of dialyzers comprised by a cylindrical polypropylene body containing a bundle of microporous hollow fibers made of polyethersulfone (PES) secured to the ends by means of hot-melt polvurethane resin. The devices are available in different models which differentiate by membrane surface area, ranging from 1.3 to 2.2 m², and for the dimensions of the outer cylindrical body in terms of length and height (306 x 41 mm for the surface areas in the range 1.3-1.5 m², 306 x 44 mm for the surface area 1.7 m² and 366 x 44 mm for the surface areas in the range 2.0-2.2 m²). Similar to other commercially available hemodialyzers, blood and dialysate flow in a countercurrent in their respective compartments. In this process, toxins and fluid are transferred across the semipermeable membrane from the blood to the dialysate compartment. The dialyzers are sterilized using moist heat with saturated steam, have a non-pyrogenic fluid path, and are labeled for single use.

The 800 series RAPIDO BLS HOLLOW-FIBRE DIAL YZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment intoxicated with poisons or drugs.

The above mentioned devices are dialyzers consisting of a cylindrical polycarbonate transparent body containing a bundle of microporous hollow fibers in highly-permeable polyethersulfone (Diapes® HF) secured to the ends by means of hot-melt polyurethane resin.