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AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSUAAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate. CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate. BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in the exact proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate. RenaCon acetate concentrate powders and liquids for acetate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.

All liquid and powder acid and bicarbonate concentrates for bicarbonate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. CitriCon liquids and powders contain Citric Acid and may contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. AcetiCon liquids and powders contain either Acetic Acid or Sodium DiAcetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. BicarboCon liquids and powders contain Sodium Bicarbonate and may contain Sodium Chloride, (both either meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed bicarbonate concentrates for bicarbonate dialysis. These products are not designed and/or formulated for reuse and should be considered as single-use only. These acid and bicarbonate concentrate liquid and powder formulations when proportioned/mixed with pretreated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrates are intended to be used in three stream hemodialysis machine in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate is proportioned into a second stream and a third stream of water that meets or exceeds current AAMI standards. Where these three streams are then mixed to prepare a final proportioned hemodialysis solution. All liquid and powder acetate concentrates for acetate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in the Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. RenaCon liquids and powders contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acetate concentrates for acetate dialysis. These products are not designed and/or formulated for re-use and should be considered as single-use only. These acetate concentrate liquid and powder formulations when proportioned/mixed with pre-treated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrate formulas are intended to be used in two stream hemodialysis machine in which an acetate concentrate is proportioned into one stream and a second stream of water that meets or exceeds current AAMI standards. Where these two streams are then mixed to prepare a final proportioned hemodialysis solution.