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For LC+100 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine. For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.

The Citric Complete™ Liquid Citric Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. These products are designed to be used as one (1) component in the preparation of dialysate in a three (3)-stream proportioning hemodialysis machine according to a physician's prescription. The subject devices are formulated to be compatible with 36.83X proportioning (proposed LC+100 series devices), as well as 45X proportioning (proposed LC+200 series devices) hemodialysis machines, in which bicarbonate concentrate is proportioned into one stream, this Citric Complete™ Liquid Acid Concentrate is proportioned into a second stream, and RO water is proportioned into third stream. These three streams are then mixed by the hemodialysis machine in distinctly specific ratios to prepared hemodialysis solution, or final dialysate. The Citric Complete™ Liquid Citric Acid Concentrate products are comprised of: USP grade sodium chloride, USP grade magnesium chloride, USP grade calcium chloride, USP grade potassium chloride, USP grade dextrose, and USP grade citric acid. The final dialysate solution is pumped to the dialysis system, known as the dialyzer or hemodialyzer, through which the patient's blood also flows in the opposite direction. The dialysate is separated from the patient's blood by semi-permeable membranes in the hemodialyzer, which passage of waste and toxins from the circulating blood into the hemodialysis solution. The used dialysate is disposed, while the patient blood is recirculated back into the patient with acute and end-stage renal failure can effectively have their blood filtered of wastes and toxins without the proper functioning of his or her kidneys.

For DA-100 series: This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine. -Or- For DA-200 series: This acid concentrate product is formulated for use in acute and to be used in conjunction with Medical yteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicalyteTM bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine. -Or- For DA-300 series: This acid concentrate product is formulated for use in acute and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.

The Nipro Dry Complete™ dry acid concentrate devices for hemodialysis are comprised of USP grade sodium chloride, USP grade magnesium chloride, USP grade calcium chloride, USP grade potassium chloride, USP grade dextrose, and USP grade acetic acid. These products may be used in conventional, commercially available hemodialysis machines or monitors as one of the necessary components of three-component hemodialysis solution, and are formulated for 36.83X (DA-100 series), 45X (DA-200 series), and 35X (DA-300 series) proportioning dialysis machines. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in an appropriately proportioned three-stream hemodialysis machines (36.83X, 45X, or 35X as specified on the device label) in which bicarbonate concentrate is proportioned into one stream, an acid solution prepared from the Nipro Dry Complete™ dry acid concentrate device 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 hemodialyzer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodialyzer 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.