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The MARS is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins. The MARS is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT). The Prismaflex control unit is intended for: - Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms . or more with acute renal failure and/or fluid overload. - Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or . more with diseases where removal of plasma components is indicated. - Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS . system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

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The Prismaflex control unit is intended for: Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

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Revaclear™ 300 and 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

This device is intended for the treatment of chronic and acute renal failure by hemodialysis. The intended population of this device is identical to those of the Polyflux HD-C4 (BIG), cleared for marketing in the United States under 510(k) notification K060195 and Polyflux HD-C4 (Small), cleared for marketing in the United States under 510(k) notification K072232. The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP), which is equivalent to the membrane utilized in the Gambro Polyflux HD-C4 (BIG) and Polyflux HD-C4 (Small) single use hemodialyzers cleared for marketing in the United States under 510(k) Notifications (K060195 and K072232). Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The MARS® is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins. The MARS® is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).

The MARS® is a blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors and a monitor unit. It is designed for the combined removal of watersoluble low and middle molecular weight substances and albumin bound molecules. The treatment is based on the dialysis of blood against an albumin-containing dialysate solution.

The Prismaflex® control unit is intended for: - Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. - Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. All treatments administered via the Prismaflex® control unit must be prescribed by a physician.

The Prismaflex control unit is a software controlled device that performs the following functions: - Loads and primes the Prismaflex disposable set automatically. - Pumps blood through the blood flow path of the Prismaflex disposable set. - Delivers anticoagulant solution into the blood flow path. - Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use. - Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies. - Controls the patient fluid removal or plasma loss according to the therapy in use. - Monitors the system and alerts the operator to abnormal situations through alarms. The Prismaflex® has a touch screen user interface that provides operating instructions. The Prismaflex® provides color coding and bar-code identification of the filter sets that are automatically loaded. The Prismaflex continually monitors the operation of the machine and displays one of four (4) types of alarms if an abnormal situation occurs. The Prismaflex® has five (5) pumps that allow multiple therapeutic combinations; including a "pre-blood pump" that allows infusion of a supplemental solution for hemodilution or anticoagulation of the extracorporeal circuit.

The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.

Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates. The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments. The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyzer where purification takes place, and back to the patient. In the dialyzer, the blood and the dialysate fluid flow on opposite surfaces of a thin Semipermeable membrane. As the blood passes through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance. Phoenix has a modular structure. It is made up of five modules that carry out independent functions: Master Module, Hydraulic Module, Blood Module, Protection Module and Bio Module. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System. The Control System manages the implementation of the physical functions.

GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.

The GamCath® High Flow Dolphin® Catheters are single use medical devices for short term use to obtain vascular access in patients with acute or chronic renal failure. The GamCath® High Flow Dolphin® Catheter combines the GamCath® High Flow Catheter with an additional coating based on a block copolymer. The polymer layer results in a surface structure that locks in barium sulfate particles. The coated catheter is free of heparin, therefore the use of the catheter is not contraindicated in patients with HIT syndrome. Catheters made of Polyurethane are equipped with small rotatable Polypropylene suture rings, still allowing rotation of catheter when sutured to skin. Polyurethane Extension lines, present on each lumen, are equipped with PVC luer-lock connectors according to ISO 594-1 with Polyethylene protection caps and are provided with clamps which may be color coded to indicate the venous (blue), arterial (red). Clamp inserts bear easily legible and permanently fixed imprints indicating usable catheter length and outer diameter of catheter shaft (in French calibration) as well as priming volumes. The Catheter is available in 13 French and 11.5 French straight and curved extension line configuration. An inner dilator made of FEP is provided in the venous lumen for insertion. The insertion length is available in range from 150 mm (5.906") up to 250 mm (9.843"). The Dolphin coating is a co-polymer film which is applied over the catheter surface to form a continuous surface that has a smoother surface morphology than an untreated catheter. The copolymer film is formed by providing a hydrophobic polymer block, such as polydimethylsiloxan (PDMS) with functional -OH end groups.

The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System. The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

The Gambro Cartridge® Blood Set Low Weight – Low Volume is single use sterile tubing set employed in the Gambro hemodialysis equipments extracorporeal circulation. It conveys the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and it is commonly referred to as bloodline. A Gambro Cartridge® Blood Set Low Weight - Low Volume can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment. The WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards. The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment. The WRO 300 H can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

The Gambro WRO 300 and WRO 300 H Water Purification Units are dialysis accessories that produce water through reverse osmosis for one hemodialysis equipment. They are both designed to maintain the low microbiological level in their flow path by the use of regular disinfection as a regular maintenance. Both WRO 300 and WRO 300 H Water Purification Units are designed with chemical disinfection capability. The WRO 300 H Water Purification Unit is also designed with heat disinfection capability. WRO 300 or WRO 300 H Water Purification Unit is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 or WRO 300 H Water Purification Unit. WRO 300 and WRO 300 H Water Purification Units utilize the Reverse Osmosis Principle. A high pressure pump forces the water through the RO membrane. The product water is further distributed to the dialysis machine. Reverse osmosis (RO) is a membrane process that is the most widely used technique for purification of water for dialysis. When the feed water is in contact with the semipermeable membrane (the most vital part of the system) and a high pressure is applied, water will flow through the membrane to the product water side. Most of the other constituents (dissolved salts, particles, bacteria and pyrogens) will remain on the feed water side of the membrane and be flushed to drain as reject water. The membrane material used for the WRO 300 and WRO 300 H Water Purification Units are Polyamide Thin-Film Composite. An acceptable quality of the feed water is required. The feed water is usually pretreated with such as active carbon filters, softener, and particle filters before it is supplied to the WRO 300 or WRO 300 H Water Purification Unit. Depending on the local water quality and regulations different pretreament equipment may be required. Gambro WRO 300 and WRO 300 H Water Purification units contain the same software package (version P4.2) which is intended for controlling water production and disinfection / clanning of the flow path of the WRO. The software also supports Heat Disinfection in the WRO 300 H Water Purification Unit.

The Prismaflex M150 Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

The Prismatlex disposable sets are sterile disposable extracomoreal circuits containing an AN69 hemofilter/dialyzer and fluid circuit for use with the Prismatlex control Unit. These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed: - . SCUF: Slow Continuous Ultrafiltration - CVVH: Continuous Veno-Venous Hemofiltration . - Continuous Veno-Venous Hemodialysis CVVHD: - CVVHDF: Continuous Veno-Venous Hemodiafiltration .