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Bicarby™ Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT). Ci-Ca Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).

The Bicarby and Ci-Ca solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (select solutions), sodium bicarbonate, and glucose. The calcium-containing solutions are available in five (5) formulations, while the calcium-free solutions are available in three (3) formulations. The Bicarby and Ci-Ca solutions are single-use, steam sterilized dialysis solutions for use in Kidney Replacement Therapy (KRT). The solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The calcium-containing solutions are designed for modalities using heparin anticoagulation, while the calcium-free solutions are intended for modalities using regional citrate anticoagulation (RCA). The calcium-free solutions sustain the anticoagulatory effect of citrate in the filter. Therefore, a separate infusion of calcium is mandatory when using these solutions.

The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.

The HemoCare Bicarbonate Concentrate Set (BCS) is the Subject Device of this submission. It consists of powdered sodium bicarbonate in a single use cartridge with an integrated tubing assembly for interfacing with hemodialysis systems with compatible three-stream proportioning connector ports such as the HemoCare Hemodialysis System. The HemoCare System uses the bicarbonate concentrate in 3-stream, 45x proportioning to generate dialysate for bicarbonate hemodialysis therapy.

pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy

pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, sodium bicarbonate, and glucose. The pureFLOW dialysis are available in four (4) formulations which differ in potassium chloride concentration.

NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.

The NxStage PureFlow Solution is a family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags.

pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

The pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (400 series only), sodium bicarbonate, and glucose. The pureFLOW dialysis solutions containing calcium are available in four (4) formulations which differ in potassium chloride concentration. The calcium-free pureFLOW dialysis solutions are available in two (2) formulations which differ in potassium chloride concentration. pureFLOW solutions are single-use, steam sterilized dialysis solutions for use in Continuous Renal Replacement Therapy (CRRT). The pureFLOW solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The calcium-containing pureFLOW 400 series solutions are used for treatment modalities using heparin anticoagulation while the calcium-free pureFLOW 500 series solutions are used for treatment modalities using regional citrate anticoagulation.

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.

The NikkiCart cartridge is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute renal failure, chronic renal failure, or acute intoxication with dialyzable substances. The NikkiCart cartridge is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning machine on the Nikkiso DBB-06 dialysis system equipped with a compatible bicarbonate cartridge holder.

The NikkiCart is a single use polypropylene (PP) cartridge containing dry sodium bicarbonate powder, which enables on-line preparation of saturated Sodium Bicarbonate solution that, in conjunction with appropriate acid concentrate solution and dialysis water, creates a bicarbonate -based dialysis fluid that meets the Association for the Advancement of Medical Instrumentation (AAMI) guidelines. When the NikkiCart is attached to the Nikkiso DBB-06 dialysis machine with a compatible bicarbonate cartridge holder, water is drawn by the dialysis machine through the cartridge, producing a saturated solution of sodium bicarbonate. The dialysis machine mixes the sodium bicarbonate solution with water and the acid concentrate to produce a bicarbonate-based dialysis fluid. The acid concentrate must have a dilution ratio of 1:44 also known as 45X to be used with the NikkiCart Sodium Bicarbonate cartridge.

The Di-Chem Inc. Hemo-Lyte C cartridge is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or intoxication with dialyzable substances.

The Di-Chem Hemo-Lyte C sodium bicarbonate cartridge for hemodialysis is a dry powder concentrate used to prepare sodium bicarbonate concentrate solution for use in conventional hemodialysis. The Hemo-Lyte C cartridge is a single use/non-refillable polypropylene cartridge containing a measured amount of sodium bicarbonate (USP Hemodialysis grade) which enables the online preparation of bicarbonate hemodialysis solution on commercially available hemodialysis machines/monitors equipped for use with bicarbonate cartridges.

Citrasate® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription. NaturaLyte® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.

Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, calcium, magnesium, and potassium), dextrose, and an organic acid source (citric acid in Citrasate and acetic acid in NaturaLyte). Citrasate also contains sodium acetate as a secondary pH adjuster. All formulation components are mixed in a single solution with dialysis quality water and provided to the customer ready for use. Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one (1) component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis. The proposed Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles have a modified cap design with alternate raw materials. The proposed bottle cap is composed of high density polyethylene (HDPE). The tamper-evident cap has a grooved ring pull tab intended to provide a thread lock. Due to the difference in cap design, the bottle threads are modified to match the threads and dimensions of the proposed cap. Dimensional changes are limited to the threads and bottle termination area only and do not affect the main bottle dimensions. There is no change in wall thickness or material used to manufacture the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles.

Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

The HBiofluids HMB32 is a bicarbonate-based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system. One chamber contains the acidic solution and one chamber contains the basic solution. At the point of use, the membrane between the two chambers is opened, and the acidic and basic solutions are mixed to form the final ionic composition of the solution to be used in the Continuous Renal Replacement Therapy (CRRT) treatment. This solution is delivered to the patient while undergoing CRRT treatment in a healthcare facility. The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500 mL +4500mL and 500mL +1500mL.