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A high permeability hemodialysis system is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that has a dialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional dialyzer. The device system consists of an extracorporeal blood system, a high permeability dialyzer, and a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient\'s blood. This highly permeable, semipermeable membrane may also permit greater loss of higher molecular weight substances from the blood, compared with the conventional dialyzer of the hemodialysis system and accessories (Sec. 876.5820). The extracorporeal blood system is the same generic type of extracorporeal blood system that is used in the hemodialysis system and accessories (Sec. 876.5820). The controlled dialysate delivery system also is similar to the conventional disalysate delivery system of the hemodialysis system and accessories (Sec. 876.5820), with the addition of an ultrafiltration controller to regulate the rate of the removal of water from the patient\'s blood and ensure that the pressure on the dialysate side of the membrane is always lower than on the blood side. This generic type of device includes the sealed dialysate delivery system.
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