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For DB-203; DB-204; DB-205; This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate on equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis. -or- For DB-206; DB-207; DB-208: This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 45x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis. -or- For DB-209; DB-210; DB-211: This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 35x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

The MedicaLyte® Bicarbonate Powder devices for bicarbonate dialysis are comprised of USP grade sodium bicarbonate for 35X (DB-209, DB-210 and DB-211) and 45X (DB-206, DB-207 and DB-208) proportioning dialysis machines and USP grade sodium bicarbonate and USP grade sodium chloride for 36.83X proportioning dialysis machines (DB-203, DB-204 and DB-These products may be used in conventional, commercially available hemodialysis 205). machines or monitors as one of the necessary components of three-component hemodialysis solution. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in three-stream hemodialysis machines in which an acid concentrate is proportioned into one stream, a bicarbonate solution is prepared from the bicarbonate powder is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodializer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodializer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.