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This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyte™ bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as Medicalyte Bicarbonate™, in a 45x three-stream artificial kidney (hemodialysis) machine.

The Citric Complete™ dry citric acid powder devices for citric acid concentrate dialysis 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. These products may be used in conventional, commercially available hemodialysis 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 45x three-stream hemodialysis machines in which bicarbonate concentrate is proportioned into one stream, a citric acid solution prepared from the Citric Complete™ dry citric acid 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 a 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, and exit 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.