Other products from "GAMBRO DIALYSATOREN GMBH"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07332414126957 955825 955825 The U9000 Plus Ultrafilter is indicated for purification of incoming water for d The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. FIP Subsystem, water purification 2 U9000 Plus ultrafilter
2 07332414114923 400 114746 Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal fai Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis KDI Dialyzer, high permeability with or without sealed dialysate system 2 Revaclear
3 07332414114916 300 114745 Revaclear 300 dialyzer is indicated for treatment of chronic and acute renal fai Revaclear 300 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis. KDI Dialyzer, high permeability with or without sealed dialysate system 2 Revaclear
4 07332414048198 210H 103580 The Polyflux 210H is intended for use in hemodialysis, hemodiafiltration and hem The Polyflux 210H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatment of chronic or acute renal failure FJI DIALYZER, CAPILLARY, HOLLOW FIBER 2 Polyflux
5 07332414048181 21L 104176 The Polyflux 21L is intended for use in haemodialysis for the treatment of chron The Polyflux 21L is intended for use in haemodialysis for the treatment of chronic or acute renal failure FJI DIALYZER, CAPILLARY, HOLLOW FIBER 2 Polyflux
6 07332414037932 170H 103579 The Polyflux 170H is intended for use in hemodialysis, hemodiafiltration and hem The Polyflux 170H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatment of chronic or acute renal failure FJI DIALYZER, CAPILLARY, HOLLOW FIBER 2 Polyflux
7 07332414037925 140H 103530 The Polyflux 140H is intended for use in hemodialysis, hemodiafiltration and hem The Polyflux 140H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatment of chronic or acute renal failure FJI DIALYZER, CAPILLARY, HOLLOW FIBER 2 Polyflux
8 07332414036423 14L 102057 The Polyflux 14L capillary dialyzer is intended for use in haemodialysis for the The Polyflux 14L capillary dialyzer is intended for use in haemodialysis for the treatment of chronic and acute renal failure. FJI DIALYZER, CAPILLARY, HOLLOW FIBER 2 Polyflux
9 07332414036416 17L 102058 The Polyflux 17L is intended for hemodialysis, for the treatment of chronic or a The Polyflux 17L is intended for hemodialysis, for the treatment of chronic or acute renal failure FJI DIALYZER, CAPILLARY, HOLLOW FIBER 2 Polyflux
10 07332414036386 6H 103403 the Polyflux 6H is intended for chronic and acute applications in haemodialysis the Polyflux 6H is intended for chronic and acute applications in haemodialysis haemofiltration and hemofiltration on small patient including pediatric indication, considering blood flow, body weight and extracoporeal blood volume KDI Dialyzer, high permeability with or without sealed dialysate system 2 Polyflux
11 07332414125721 500 955692 Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, exp Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure. QAX Hemodialyzer with expanded solute removal profile 2 THERANOVA
12 07332414125714 400 955691 Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, exp Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure. QAX Hemodialyzer with expanded solute removal profile 2 THERANOVA
13 07332414102500 112062 112062 The U9000 Ultrafilter is indicated for purification of incoming water for dialys The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. FIP Subsystem, water purification 2 Ultrafilter U 9000
14 07332414015480 150C 101097 The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which cont The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which contains 150 grams of cellulose-coated activated charcoal. The device is filled with physiological saline solution prior to sterilization. FLD Apparatus, hemoperfusion, sorbent 2 Adsorba Hemoperfusion cartridge
15 07332414015473 300C 101223 The Adsorba 300C hemoperfusion cartridge is a steam sterilized device which cont The Adsorba 300C hemoperfusion cartridge is a steam sterilized device which contains 300 grams of cellulose-coated activated charcoal. The device is filled with physiological saline solution prior to sterilization. FLD Apparatus, hemoperfusion, sorbent 2 Adsorba Hemoperfusion cartridge
16 07332414047108 10LR 104311 The POLyflux LR is intended for use in hemodialysis for the treatment of chronic The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient MSF,KDI,FJI HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high permeability with or without seal HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high permeability with or without sealed dialysate system,DIALYZER, CAPILLARY, HOLLOW FIBER 2 POLYFLUX
17 07332414041472 8LR 104333 The POLyflux LR is intended for use in hemodialysis for the treatment of chronic The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient MSF,KDI,FJI HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high permeability with or without seal HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high permeability with or without sealed dialysate system,DIALYZER, CAPILLARY, HOLLOW FIBER 2 POLYFLUX
18 07332414041465 6LR 104329 The POLyflux LR is intended for use in hemodialysis for the treatment of chronic The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient KDI,FJI,MSF Dialyzer, high permeability with or without sealed dialysate system,DIALYZER, CA Dialyzer, high permeability with or without sealed dialysate system,DIALYZER, CAPILLARY, HOLLOW FIBER,HEMODIALYZER, RE-USE, HIGH FLUX 2 POLYFLUX
19 07332414031787 21R 100691 Polyflux R is intended for use in hemodialysis for the treatment of chronic and Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient KDI,MSF,FJI Dialyzer, high permeability with or without sealed dialysate system,HEMODIALYZER Dialyzer, high permeability with or without sealed dialysate system,HEMODIALYZER, RE-USE, HIGH FLUX,DIALYZER, CAPILLARY, HOLLOW FIBER 2 POLYFLUX
20 07332414031770 17R 101785 Polyflux R is intended for use in hemodialysis for the treatment of chronic and Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient MSF,KDI,FJI HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high permeability with or without seal HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high permeability with or without sealed dialysate system,DIALYZER, CAPILLARY, HOLLOW FIBER 2 POLYFLUX
21 07332414126209 Revaclear 400 114746M Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal f Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis. KDI Dialyzer, high permeability with or without sealed dialysate system 2 REVACLEAR
22 07332414126193 Revaclear 300 114745M Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal f Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis. KDI Dialyzer, high permeability with or without sealed dialysate system 2 REVACLEAR
Other products with the same Product Codes "FJI, MSF, KDI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00085412639505 955630 955630 The TherMax blood warmer is an accessory device intended for use with the PrisMa The TherMax blood warmer is an accessory device intended for use with the PrisMax system and appropriate blood warmer compatible Prismaflex sets for the therapy in use. The blood warmer heats the return blood flow during a PrisMax system treatment in order to replace heat lost to the atmosphere and replacement fluids. therMaxTherMax Blood Warmer BAXTER HEALTHCARE CORPORATION
2 00085412639499 955626 955626 The PrisMax control unit is a software controlled single patient device that per The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy prisMaxPrisMax System BAXTER HEALTHCARE CORPORATION
3 00085412090429 XPH210 H25606A Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or ch Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Xenium XPH Dialyzer BAXTER INTERNATIONAL INC.
4 00085412090412 XPH190 H25605A Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or ch Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Xenium XPH Dialyzer BAXTER INTERNATIONAL INC.
5 00085412090405 XPH170 H25604A Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or ch Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Xenium XPH Dialyzer BAXTER INTERNATIONAL INC.
6 00085412090399 XPH150 H25603A Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or ch Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Xenium XPH Dialyzer BAXTER INTERNATIONAL INC.
7 00085412090382 XPH130 H25602A Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or ch Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Xenium XPH Dialyzer BAXTER INTERNATIONAL INC.
8 00085412090375 XPH110 H25601A Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or ch Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Xenium XPH Dialyzer BAXTER INTERNATIONAL INC.
9 00085412071275 150 5M2119 Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients w Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Exeltra Dialyzer BAXTER INTERNATIONAL INC.
10 00085412071244 210 5M2132 Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients w Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Exeltra Dialyzer BAXTER INTERNATIONAL INC.
11 00085412071220 190 5M2121 Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients w Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Exeltra Dialyzer BAXTER INTERNATIONAL INC.
12 00085412071213 170 5M2120 Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients w Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. Exeltra Dialyzer BAXTER INTERNATIONAL INC.
13 B815SM2000030 SM-200-003 SM-200-003 The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. SAMI Hemofiltration Cassette DIALCO MEDICAL INC
14 B815SM1000030 SM-100-003 SM-100-003 The SAMI RRT Unit is a software controlled device that performs the following fu The SAMI RRT Unit is a software controlled device that performs the following functions: - Primes the disposable cassette automatically,- Pumps blood through the blood flow path of the disposable cassette,- Delivers anticoagulant into the blood flow path,- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,- Controls the patient fluid removal or plasma loss according to the therapy in use,- Monitors the system and alerts the operator of abnormal situations through alarms.The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set. SAMI RRT System DIALCO MEDICAL INC
15 B815SA400000 SA-400-00 SA-400-00 The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. SAMI RRT Cassette DIALCO MEDICAL INC
16 B815SA300000 SA-300-00 SA-300-00 The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. SAMI Hemofiltration Cassette DIALCO MEDICAL INC
17 B815SA100010 SA-100-01 SA-100-01 The SAMI RRT Unit is a software controlled device that performs the following fu The SAMI RRT Unit is a software controlled device that performs the following functions: - Primes the disposable cassette automatically,- Pumps blood through the blood flow path of the disposable cassette,- Delivers anticoagulant into the blood flow path,- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,- Controls the patient fluid removal or plasma loss according to the therapy in use,- Monitors the system and alerts the operator of abnormal situations through alarms.The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set. SAMI RRT DIALCO MEDICAL INC
18 B815DM850000 DM-850-00 DM-850-00 The DIMI RRT System is a software controlled device that performs the following The DIMI RRT System is a software controlled device that performs the following functions: - Primes the disposable cassette automatically,- Pumps blood through the blood flow path of the disposable cassette,- Delivers anticoagulant into the blood flow path,- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,- Controls the patient fluid removal or plasma loss according to the therapy in use,- Monitors the system and alerts the operator of abnormal situations through alarms.The DIMI RRT System has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set. DIMI RRT System DIALCO MEDICAL INC
19 B815DI400000 DI-400-00 DI-400-00 The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. DIMI RRT Cassette DIALCO MEDICAL INC
20 B173SM2000030 SM-200-003 SM-200-003 The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. SAMI Hemofiltration Cassette SPECTRAL MEDICAL INC
21 B173SM1000030 SM-100-003 SM-100-003 The SAMI RRT Unit is a software controlled device that performs the following fu The SAMI RRT Unit is a software controlled device that performs the following functions:- Primes the disposable cassette automatically.- Pumps blood through the blood flow path of the disposable cassette.- Delivers anticoagulant into the blood flow path.- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapyin use.- Pumps sterile dialysate into the fluid compartment of the filter in RRT 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 SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the Cassette tubing set. SAMI RRT SPECTRAL MEDICAL INC
22 B173SA400000 SA-400-00 SA-400-00 The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure.The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. SAMI RRT Cassette SPECTRAL MEDICAL INC
23 B144MPC60DR1 MPC-60D-R MPC-60D-R Dialysate Port Storage Cap - Red Molded Products, Inc. MOLDED PRODUCTS, INC.
24 B144MPC60D1 MPC-60D MPC-60D Dialysate Port Storage Cap Molded Products, Inc. MOLDED PRODUCTS, INC.
25 B144MPC60B1 MPC-60B MPC-60B Blood Port Kidney Storage Cap - Push On Molded Products, Inc. MOLDED PRODUCTS, INC.
26 B144MPC50DVY1 MPC-50DV-Y MPC-50DV-Y Vented Dialysate Port, Storage Cap - Yellow Molded Products, Inc. MOLDED PRODUCTS, INC.
27 B144MPC50DV1 MPC-50DV MPC-50DV Vented Dialysate Port, Storage Cap Molded Products, Inc. MOLDED PRODUCTS, INC.
28 B144MPC451 MPC-45 MPC-45 Kidney Storage Cap - Blood Port Molded Products, Inc. MOLDED PRODUCTS, INC.
29 B144MPC40S0 MPC-40-S MPC-40-S Kidney Storage Cap - Blood Port, Sterile Molded Products, Inc. MOLDED PRODUCTS, INC.
30 B144MPC401 MPC-40 MPC-40 Blood Port Kidney Storage Cap - Twist On Molded Products, Inc. MOLDED PRODUCTS, INC.
31 37332414107728 800541 800541 The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be use The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device (produced by Gambro Lundia AB) for MARS therapy. MARS TREATMENT KIT TYPE 1116/1 - X-MARS US GAMBRO AB
32 37332414106936 800437 800437 The MARS Monitor is a mechanical detoxification device used in conjunction with The MARS Monitor is a mechanical detoxification device used in conjunction with a renal replacement therapy system (companion device) for the removal of dialyzable (unbound) toxins, which are either water-soluble or, in the bound form, associated with serum albumin. MARS Monitor GAMBRO AB
33 20860113000656 2.0 CLR 2.0 The SeaStar CLR 2.0 hemofilter is indicated for use in patients with fluid overl The SeaStar CLR 2.0 hemofilter is indicated for use in patients with fluid overload, uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy. CLR SEASTAR MEDICAL, INC.
34 20850001011024 PN-0000503 ST-100 Tablo Straws OUTSET MEDICAL, INC.
35 10853072007289 210104 210104 For use with the Aquadex System. The Aquadex System is indicated for: Continuous For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. AquaFlexFlow UF 500 Plus - 24 Hr NUWELLIS INC.
36 10853072007128 114157 114157 For use with the Aquadex System. The Aquadex System is indicated for: Continuous For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. AquaFlexFlow UF 500 NUWELLIS INC.
37 10853072007111 114156 114156 For use with the Aquadex System. The Aquadex System is indicated for: Continuous For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. AquaFlexFlow UF 500 Plus NUWELLIS INC.
38 10853072007104 120100 120100 The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therap The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. Aquadex SmartFlow Console NUWELLIS INC.
39 10853072007074 114158 114158 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. Aquadex FlexFlow NUWELLIS INC.
40 10853072007029 UF 500-HCT 114156 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. Blood Circuit Set NUWELLIS INC.
41 10853072007005 UF 500 114157 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. Blood Circuit Set NUWELLIS INC.
42 M535SSK5350 SSK-535 NXSTAGE SPEEDSWAP EXPRESS KIT NXSTAGE MEDICAL, INC.
43 M535SLE3011M30980 SLE-3011M3098 Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie MEDISYSTEMS CORPORATION
44 M535SLE3010M30960 SLE-3010M3096 Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie MEDISYSTEMS CORPORATION
45 M535SLE3000M30950 SLE-3000M3095 Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri MEDISYSTEMS CORPORATION
46 M535NX3302A0 NX3302-A NX3302-A NXView Touch Monitor NXSTAGE MEDICAL, INC.
47 M535NX1274A0 NX1274-A NXVIEW TOUCH SCREEN NXSTAGE MEDICAL, INC.
48 M535NX12740 NX1274 NXVIEW TOUCH SCREEN NXSTAGE MEDICAL, INC.
49 M535NX10005A0 NX1000-5-A NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
50 M535NX100050 NX1000-5 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.