High Permeability with/without Sealed Dialysate System Suppliers
Limit companies to: Worldwide USA
Edwards Lifesciences Corporation | Address: One Edwards Way, Irvine, California 92614, USA 
www.edwards.com | Send Inquiry | Phone: +1-(949)-250-2500
FDA Registration: 2015691 Year Established: 1958 Annual Revenues: USD 1-5 Million Employee Count: ~5600 Quality: ISO 9001, CE Certified
Products: Annuloplasty Devices, Aortic Root Bioprostheses, Bioprosthetic Aortic Valves, Bioprosthetic Mitral Valves, Dopplers, Thrombectomy Devices, ...
Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics a more...
www.edwards.com | Send Inquiry | Phone: +1-(949)-250-2500
FDA Registration: 2015691 Year Established: 1958 Annual Revenues: USD 1-5 Million Employee Count: ~5600 Quality: ISO 9001, CE Certified
Products: Annuloplasty Devices, Aortic Root Bioprostheses, Bioprosthetic Aortic Valves, Bioprosthetic Mitral Valves, Dopplers, Thrombectomy Devices, ...
Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics a more...
Transvivo Inc. | Address: 3067 Research Drive, Richmond, California 94806, USA
www.omnifloinc.com | Phone: +1-(510)-223-1054
Products: Fluid Management Systems, Continuous Renal Replacement Therapy, Hemofiltration Unit, High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
Transvivo Inc. deals with blood purification and fluid management systems. Our Omni-DL™ system offers real-time treatment information, context-sensitive graphical help, and charting assistance. more...
www.omnifloinc.com | Phone: +1-(510)-223-1054
Products: Fluid Management Systems, Continuous Renal Replacement Therapy, Hemofiltration Unit, High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
Transvivo Inc. deals with blood purification and fluid management systems. Our Omni-DL™ system offers real-time treatment information, context-sensitive graphical help, and charting assistance. more...
Fresenius Medical Care North America | Address: 2637 Shadelands Dr., Walnut Creek, California 94598, USA
www.fmc-ag.com | Phone: +1-(800)-227-2572
FDA Registration: 2937457 Annual Revenues: > USD 1 Billion Employee Count: ~37230
Products: Anesthesia Infusion Pump Tubing, Anesthetic Infusion Pump (FDA Code: FRN), Adult-Pediatric Volumetric Infusion Pumps, Autotransfusion Apparatus (FDA Code: CAC), Automatic Delivery Peritoneal System (FDA Code: FKX), Dialysis Temperature Monitor (FDA Code: FLA), ...
Fresenius Medical Care North America is a provider of products and services for individuals undergoing dialysis. We define the highest standards for the treatment of patients with chronic kidney failu more...
www.fmc-ag.com | Phone: +1-(800)-227-2572
FDA Registration: 2937457 Annual Revenues: > USD 1 Billion Employee Count: ~37230
Products: Anesthesia Infusion Pump Tubing, Anesthetic Infusion Pump (FDA Code: FRN), Adult-Pediatric Volumetric Infusion Pumps, Autotransfusion Apparatus (FDA Code: CAC), Automatic Delivery Peritoneal System (FDA Code: FKX), Dialysis Temperature Monitor (FDA Code: FLA), ...
Fresenius Medical Care North America is a provider of products and services for individuals undergoing dialysis. We define the highest standards for the treatment of patients with chronic kidney failu more...
Gambro | Address: 14143 Denver West Parkway, Lakewood, Colorado 80401, USA
www.gambroamericas.com | Send Inquiry | Phone: +1-(800)-525-2623
Products: Monitoring Systems, Hemo Dialyzers, Water Purification Systems, Cardiac Stress Blood Pressure Monitoring System, Hemodialysis Blood Circuit Accessories (FDA Code: KOC), Hollow Fiber Capillary Dialyzer (FDA Code: FJI), ...
Gambro offers in-center hemodialysis and intensive care products. Our Polyflux® dialyzer provides sieving properties with an asymmetric 3-layer structured membrane. It has a sharp cut-off that pro more...
www.gambroamericas.com | Send Inquiry | Phone: +1-(800)-525-2623
Products: Monitoring Systems, Hemo Dialyzers, Water Purification Systems, Cardiac Stress Blood Pressure Monitoring System, Hemodialysis Blood Circuit Accessories (FDA Code: KOC), Hollow Fiber Capillary Dialyzer (FDA Code: FJI), ...
Gambro offers in-center hemodialysis and intensive care products. Our Polyflux® dialyzer provides sieving properties with an asymmetric 3-layer structured membrane. It has a sharp cut-off that pro more...
Baxter Healthcare Corp., Renal Division | Address: 7511 114th Avenue North, Largo, Florida 33777, USA
baxter.com | Send Inquiry | Phone: +1-(847)-948-2000
FDA Registration: 1036337
Products: Blood Transfusion Sets (FDA Code: BRZ), Blood Bank Supplies (FDA Code: KSS), Blood Mixing and Weighing Device (FDA Code: KSQ), Blood Transfer Unit (FDA Code: KSB), Blood & Components Collection Container (FDA Code: KSR), Automatic Delivery Peritoneal System (FDA Code: FKX), ...
Baxter Healthcare Corp., Renal Division develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, tr more...
baxter.com | Send Inquiry | Phone: +1-(847)-948-2000
FDA Registration: 1036337
Products: Blood Transfusion Sets (FDA Code: BRZ), Blood Bank Supplies (FDA Code: KSS), Blood Mixing and Weighing Device (FDA Code: KSQ), Blood Transfer Unit (FDA Code: KSB), Blood & Components Collection Container (FDA Code: KSR), Automatic Delivery Peritoneal System (FDA Code: FKX), ...
Baxter Healthcare Corp., Renal Division develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, tr more...
Baxter International Inc | Address: One Baxter Parkway, Deerfield, Illinois 60015-4625, USA
www.baxter.com | Phone: +1-(847)-948-4770, 800-422-9837
FDA Registration: 2025695 Year Established: 1931
Products: Anesthesia Equipment, Ambulatory Pumps, Analgesics, Anesthesia, Anesthesia Delivery Unit, Anesthesia Equipment, ...
Baxter International Inc. provides medicines for hemophilia, immune disorders, kidney disease and cancer. We manufacture plasma-based and recombinant proteins used to treat hemophilia. We offer biopha more...
www.baxter.com | Phone: +1-(847)-948-4770, 800-422-9837
FDA Registration: 2025695 Year Established: 1931
Products: Anesthesia Equipment, Ambulatory Pumps, Analgesics, Anesthesia, Anesthesia Delivery Unit, Anesthesia Equipment, ...
Baxter International Inc. provides medicines for hemophilia, immune disorders, kidney disease and cancer. We manufacture plasma-based and recombinant proteins used to treat hemophilia. We offer biopha more...
Aksys, Ltd. | Address: Two Marriott Drive, Lincolnshire, Illinois 60069-3700, USA
Phone: +1-(847)-229-2020
Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~90
Products: High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
Aksys, Ltd. specializes in hemodialysis products and services. Our automated personal hemodialysis system (PHD), known as the Aksys PHD is designed to enable patients to perform frequent hemodialysis more...
Phone: +1-(847)-229-2020
Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~90
Products: High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
Aksys, Ltd. specializes in hemodialysis products and services. Our automated personal hemodialysis system (PHD), known as the Aksys PHD is designed to enable patients to perform frequent hemodialysis more...
BL Healthcare, Inc. | Address: 33 Commercial St., Suite #3, Foxboro, Massachusetts 02035, USA
www.blhealthcare.com | Send Inquiry | Phone: +1-(508)-543-4150
FDA Registration: 3006782137
Products: Interactive Patient Communication System, Radiofrequency Physiological Transmitter/Receiver System (FDA Code: DRG), High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
BL Healthcare, Inc. is a provider of remote health management solutions to the health care industry. We offer TV based, dedicated and K-box products. The TV based systems work by set-top box that turn more...
www.blhealthcare.com | Send Inquiry | Phone: +1-(508)-543-4150
FDA Registration: 3006782137
Products: Interactive Patient Communication System, Radiofrequency Physiological Transmitter/Receiver System (FDA Code: DRG), High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
BL Healthcare, Inc. is a provider of remote health management solutions to the health care industry. We offer TV based, dedicated and K-box products. The TV based systems work by set-top box that turn more...
Nxstage Medical, Inc. | Address: 439 South Union St., 5th Floor, Lawrence, Massachusetts 01843, USA
www.nxstage.com | Phone: +1-(978)-687-4700, 866-697-8243
FDA Registration: 3009141079
Products: Laboratory Grade Water Purification Systems, Millipore Water Purification Systems, Analytical-Grade Water Purification Systems, Solar Powered Water Purification Systems, Lab Water Purification Systems, Water Purification Subsystem (FDA Code: FIP), ...
Nxstage Medical, Inc. specializes in bloodlines, needles and products for in-center dialysis and pheresis applications. Our NxStage System One™ helps make daily and home therapy more accessible. more...
www.nxstage.com | Phone: +1-(978)-687-4700, 866-697-8243
FDA Registration: 3009141079
Products: Laboratory Grade Water Purification Systems, Millipore Water Purification Systems, Analytical-Grade Water Purification Systems, Solar Powered Water Purification Systems, Lab Water Purification Systems, Water Purification Subsystem (FDA Code: FIP), ...
Nxstage Medical, Inc. specializes in bloodlines, needles and products for in-center dialysis and pheresis applications. Our NxStage System One™ helps make daily and home therapy more accessible. more...
CHF Solutions, Inc. | Address: 7601 Northland Dr. Ste. 170, Brooklyn Center, Minnesota 55428, USA
www.chfsolutions.com | Send Inquiry | Phone: +1-(763)-463-4600
FDA Registration: 3003504604
Products: High Permeability with/without Sealed Dialysate System (FDA Code: KDI), Single Patient Dialysate Delivery System (FDA Code: FKP), ...
CHF Solutions, Inc. is a privately held manufacturer of medical devices for cardiac care. We develop aquapheresis therapy and the Aquadex FlexFlow fluid removal system, which are designed specifically more...
www.chfsolutions.com | Send Inquiry | Phone: +1-(763)-463-4600
FDA Registration: 3003504604
Products: High Permeability with/without Sealed Dialysate System (FDA Code: KDI), Single Patient Dialysate Delivery System (FDA Code: FKP), ...
CHF Solutions, Inc. is a privately held manufacturer of medical devices for cardiac care. We develop aquapheresis therapy and the Aquadex FlexFlow fluid removal system, which are designed specifically more...
Minntech Corporation | Address: 14605 28th Avenue N., Minneapolis, Minnesota 55447, USA
www.minntech.com | Send Inquiry | Phone: +1-(763)-553-3300, 800-328-3345
FDA Registration: 2150060 Year Established: 1974 Annual Revenues: USD 25-50 Million Employee Count: ~400 Quality: ISO 9001, CE Certified
Products: Air Bubble Detectors (FDA Code: FJF), Air Bubble Monitor (FDA Code: FJF), Cardiopulmonary Bypass Accessories (FDA Code: KRI), Cardiopulmonary Bypass Oxygenator (FDA Code: DTZ), Central Multiple Patient Dialysate Delivery System (FDA Code: FKQ), Bicarbonate Hemodialysis Concentrates, ...
Minntech Corporation develops, manufactures and markets medical devices, sterilants, & water purification products. We also develop core technologies in hollow fiber membrane devices, chemical sterila more...
www.minntech.com | Send Inquiry | Phone: +1-(763)-553-3300, 800-328-3345
FDA Registration: 2150060 Year Established: 1974 Annual Revenues: USD 25-50 Million Employee Count: ~400 Quality: ISO 9001, CE Certified
Products: Air Bubble Detectors (FDA Code: FJF), Air Bubble Monitor (FDA Code: FJF), Cardiopulmonary Bypass Accessories (FDA Code: KRI), Cardiopulmonary Bypass Oxygenator (FDA Code: DTZ), Central Multiple Patient Dialysate Delivery System (FDA Code: FKQ), Bicarbonate Hemodialysis Concentrates, ...
Minntech Corporation develops, manufactures and markets medical devices, sterilants, & water purification products. We also develop core technologies in hollow fiber membrane devices, chemical sterila more...
Nephros, Inc. | Address: 41 Grand Ave, Suite 200, River Edge, New Jersey 07661, USA
www.nephros.com | Send Inquiry | Phone: +1-(201)-3435202
FDA Registration: 3003337893
Products: Ultrapure Grade Water Purification Systems, Hemodialysis systems, High Permeability with/without Sealed Dialysate System (FDA Code: KDI), Ultra Water Filters, Dual Stage, ...
Nephros, Inc. deals with therapies for end stage renal disease and immuno-compromised patients. We develop ultrapure water, which removes bacteria, viruses, fungi, parasites, and biological toxins suc more...
www.nephros.com | Send Inquiry | Phone: +1-(201)-3435202
FDA Registration: 3003337893
Products: Ultrapure Grade Water Purification Systems, Hemodialysis systems, High Permeability with/without Sealed Dialysate System (FDA Code: KDI), Ultra Water Filters, Dual Stage, ...
Nephros, Inc. deals with therapies for end stage renal disease and immuno-compromised patients. We develop ultrapure water, which removes bacteria, viruses, fungi, parasites, and biological toxins suc more...
Npbi Intl. Bv | Address: Runde Zz 41, Emmer Compascuum, HM 7881, Netherlands
Phone: 49-617-26080
FDA Registration: 9610969
Products: Autotransfusion Apparatus (FDA Code: CAC), Blood Bank Supplies (FDA Code: KSS), Blood Mixing and Weighing Device (FDA Code: KSQ), Blood & Components Collection Container (FDA Code: KSR), Heat-Sealing Device (FDA Code: KSD), Therapeutic Automated Blood Cell and Plasma Separator (FDA Code: LKN), ...
Npbi Intl. Bv deals with medical devices and diagnostics. We supply medical, precision and optical instruments. more...
Phone: 49-617-26080
FDA Registration: 9610969
Products: Autotransfusion Apparatus (FDA Code: CAC), Blood Bank Supplies (FDA Code: KSS), Blood Mixing and Weighing Device (FDA Code: KSQ), Blood & Components Collection Container (FDA Code: KSR), Heat-Sealing Device (FDA Code: KSD), Therapeutic Automated Blood Cell and Plasma Separator (FDA Code: LKN), ...
Npbi Intl. Bv deals with medical devices and diagnostics. We supply medical, precision and optical instruments. more...
Erika De Reynosa, S.A. De C.V. | Address: Brecha E99 Sur; Parque, Industrial Reynos, Bldg. Ii, Cd, Reynosa, Tamps, Mexico
Phone: +52-(899)-921-3500
FDA Registration: 8030665
Products: Intravenous Administration Kit (FDA Code: FPA), Automatic Delivery Peritoneal System (FDA Code: FKX), Dialysis Start/Stop Tray (FDA Code: FKG), Disposable Kidney Perfusion Kit (FDA Code: KDL), Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ), Hemodialysis Blood Circuit Accessories (FDA Code: KOC), ...
Erika De Reynosa, S.A. De C.V. specializes in offering orthopedic, prosthetic and surgical appliances & supplies. Our products include tubing clamps, catheter connectors, I.V. administration sets, sin more...
Phone: +52-(899)-921-3500
FDA Registration: 8030665
Products: Intravenous Administration Kit (FDA Code: FPA), Automatic Delivery Peritoneal System (FDA Code: FKX), Dialysis Start/Stop Tray (FDA Code: FKG), Disposable Kidney Perfusion Kit (FDA Code: KDL), Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ), Hemodialysis Blood Circuit Accessories (FDA Code: KOC), ...
Erika De Reynosa, S.A. De C.V. specializes in offering orthopedic, prosthetic and surgical appliances & supplies. Our products include tubing clamps, catheter connectors, I.V. administration sets, sin more...
Oita Works, Asahi Kasei Kuraray Medical Co., Ltd. | Address: 2111-2 Oaza Sato, Oita-Shi 870-0396, Japan
Phone: +81-(847)-4988500
FDA Registration: 8010002
Products: Blood Transfusion Microfilter (FDA Code: CAK), High Permeability with/without Sealed Dialysate System (FDA Code: KDI), Therapeutic Automated Blood Cell and Plasma Separator (FDA Code: LKN), Membrane Automated Blood Cell/Plasma Separator For Therapeutic Purposes (FDA Code: MDP), Artifical Eye Cleaning/Lubricating Solution (FDA Code: MSI), Low Flux Re-Use Hemodialyzer (FDA Code: MSE), ...
Oita Works, Asahi Kasei Kuraray Medical Co., Ltd. provides therapeutic automated blood cell and plasma separator & hollow fiber capillary dialyzers. more...
Phone: +81-(847)-4988500
FDA Registration: 8010002
Products: Blood Transfusion Microfilter (FDA Code: CAK), High Permeability with/without Sealed Dialysate System (FDA Code: KDI), Therapeutic Automated Blood Cell and Plasma Separator (FDA Code: LKN), Membrane Automated Blood Cell/Plasma Separator For Therapeutic Purposes (FDA Code: MDP), Artifical Eye Cleaning/Lubricating Solution (FDA Code: MSI), Low Flux Re-Use Hemodialyzer (FDA Code: MSE), ...
Oita Works, Asahi Kasei Kuraray Medical Co., Ltd. provides therapeutic automated blood cell and plasma separator & hollow fiber capillary dialyzers. more...
Toyokagaku Co., Ltd. | Address: 1008 Terajiri-Oaza, Hino-Cho, Gamo-Gun, Shiga-Pref., Japan
www.toyokagaku.com | Phone: +81-(748)-52-5000
FDA Registration: 3003793596
Products: Adhesive Bandages (FDA Code: KGX), Adhesive Elastic Bandage Tape, Elastic Adhesive Bandages, Non-Adhesive Bandages, Flexible Fabric Adhesive Bandages, Adhesive Bandage Strip, ...
Toyokagaku Co., Ltd. is a manufacturer of medical tools, over-the-counter medications, medical treatment products, hygiene products and other medical related products. more...
www.toyokagaku.com | Phone: +81-(748)-52-5000
FDA Registration: 3003793596
Products: Adhesive Bandages (FDA Code: KGX), Adhesive Elastic Bandage Tape, Elastic Adhesive Bandages, Non-Adhesive Bandages, Flexible Fabric Adhesive Bandages, Adhesive Bandage Strip, ...
Toyokagaku Co., Ltd. is a manufacturer of medical tools, over-the-counter medications, medical treatment products, hygiene products and other medical related products. more...
Nipro Corporation | Address: 3-9-3, Honjo-Nishi, Kita-Ku, Osaka, JP-27 531-8510, Japan
www.nipro.co.jp | Phone: +81-(06)-6372-2331
FDA Registration: 8041145
Products: Fistula Needle (FDA Code: FIE), Guidewire Catheter (FDA Code: DQX), Single Lumen Hypodermic Needle (FDA Code: FMI), Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK), Dialysis Transducer Protector (FDA Code: FIB), Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ), ...
Nipro Corporation is a provider of disposable medical products. Our vacuum blood collection tube reduces blood coagulation time, and utilizes thrombin and a thrombin-like enzyme as coagulation acceler more...
www.nipro.co.jp | Phone: +81-(06)-6372-2331
FDA Registration: 8041145
Products: Fistula Needle (FDA Code: FIE), Guidewire Catheter (FDA Code: DQX), Single Lumen Hypodermic Needle (FDA Code: FMI), Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK), Dialysis Transducer Protector (FDA Code: FIB), Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ), ...
Nipro Corporation is a provider of disposable medical products. Our vacuum blood collection tube reduces blood coagulation time, and utilizes thrombin and a thrombin-like enzyme as coagulation acceler more...
Nikkiso Co. Ltd. | Address: 2-16-2, Noguchi-cho, Higashimurayama, Tokyo 150-8677, Japan
www.nikkiso.com | Phone: +81-(3)-392-3311
FDA Registration: 8031561
Products: Constant-flow Infusion Pump, Batteries & Battery Assemblies for Infusion Pumps, Anesthesia Infusion Pump Tubing, Anesthetic Infusion Pump (FDA Code: FRN), Adult-Pediatric Volumetric Infusion Pumps, Peristaltic Infusion Pump (FDA Code: FRN), ...
Nikkiso Co. Ltd. specializes in the production of medical equipment. Our product line includes hemodialysis machine and related devices, dialyzers, blood tubing sets, hemodialysis communication system more...
www.nikkiso.com | Phone: +81-(3)-392-3311
FDA Registration: 8031561
Products: Constant-flow Infusion Pump, Batteries & Battery Assemblies for Infusion Pumps, Anesthesia Infusion Pump Tubing, Anesthetic Infusion Pump (FDA Code: FRN), Adult-Pediatric Volumetric Infusion Pumps, Peristaltic Infusion Pump (FDA Code: FRN), ...
Nikkiso Co. Ltd. specializes in the production of medical equipment. Our product line includes hemodialysis machine and related devices, dialyzers, blood tubing sets, hemodialysis communication system more...
Terumo Corporation | Address: 44-1, 2-Chome, Hatagaya, Shibuya-ku, Tokyo 151-0072, Japan
www.terumo.co.jp | Send Inquiry | Phone: +81-(3)-3374-8111
FDA Registration: 9681834
Products: Allergy Syringes/Trays, Artery Vascular Clamp (FDA Code: DXC), Arterial Line Cardiopulmonary Bypass Blood Filter (FDA Code: DTM), Alpha-1-Antitrypsin (FDA Code: DEM), Antistick Syringe (FDA Code: MEG), Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ), ...
Terumo Corporation manufactures & distributes medical products & equipment that include pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, pe more...
www.terumo.co.jp | Send Inquiry | Phone: +81-(3)-3374-8111
FDA Registration: 9681834
Products: Allergy Syringes/Trays, Artery Vascular Clamp (FDA Code: DXC), Arterial Line Cardiopulmonary Bypass Blood Filter (FDA Code: DTM), Alpha-1-Antitrypsin (FDA Code: DEM), Antistick Syringe (FDA Code: MEG), Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ), ...
Terumo Corporation manufactures & distributes medical products & equipment that include pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, pe more...
Medica S.r.l. | Address: 6, Via Degli Artigiani, Medolla 41036, Italy
www.medica.it | Send Inquiry | Phone: +39-(535)-51159
Products: High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
Medica S.r.l. offers dialysis products, plasma filters and medical plastic components. Our ARM-Two™ is an automatic four-station system for dialyzer washing and reprocessing procedures. It has a more...
www.medica.it | Send Inquiry | Phone: +39-(535)-51159
Products: High Permeability with/without Sealed Dialysate System (FDA Code: KDI), ...
Medica S.r.l. offers dialysis products, plasma filters and medical plastic components. Our ARM-Two™ is an automatic four-station system for dialyzer washing and reprocessing procedures. It has a more...
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FDA Code / Regulation: KDI / 876.5860
A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:
Classification. Class II. The special controls for this device are FDA's:
