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 | 07332414036140 | 24R | 104324 | 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 | FJI,MSF,KDI | DIALYZER, CAPILLARY, HOLLOW FIBER,HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high DIALYZER, CAPILLARY, HOLLOW FIBER,HEMODIALYZER, RE-USE, HIGH FLUX,Dialyzer, high permeability with or without sealed dialysate system | 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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 |
2 | 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 |
3 | 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 |
4 | B144MPC60DR1 | MPC-60D-R | MPC-60D-R | Dialysate Port Storage Cap - Red | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
5 | B144MPC60D1 | MPC-60D | MPC-60D | Dialysate Port Storage Cap | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
6 | B144MPC60B1 | MPC-60B | MPC-60B | Blood Port Kidney Storage Cap - Push On | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
7 | B144MPC50DVY1 | MPC-50DV-Y | MPC-50DV-Y | Vented Dialysate Port, Storage Cap - Yellow | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
8 | B144MPC50DV1 | MPC-50DV | MPC-50DV | Vented Dialysate Port, Storage Cap | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
9 | B144MPC451 | MPC-45 | MPC-45 | Kidney Storage Cap - Blood Port | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
10 | B144MPC40S0 | MPC-40-S | MPC-40-S | Kidney Storage Cap - Blood Port, Sterile | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
11 | B144MPC401 | MPC-40 | MPC-40 | Blood Port Kidney Storage Cap - Twist On | Molded Products, Inc. | MOLDED PRODUCTS, INC. |
12 | 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 |
13 | 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 |
14 | 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. |
15 | 20850001011024 | PN-0000503 | ST-100 | Tablo Straws | OUTSET MEDICAL, INC. | |
16 | 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. |
17 | 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. |
18 | 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. |
19 | 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. |
20 | 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. |
21 | 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. |
22 | 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. |
23 | M535SSK5350 | SSK-535 | NXSTAGE SPEEDSWAP EXPRESS KIT | NXSTAGE MEDICAL, INC. | ||
24 | M535SLE3011M30980 | SLE-3011M3098 | Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | MEDISYSTEMS CORPORATION | ||
25 | M535SLE3010M30960 | SLE-3010M3096 | Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | MEDISYSTEMS CORPORATION | ||
26 | M535SLE3000M30950 | SLE-3000M3095 | Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri | MEDISYSTEMS CORPORATION | ||
27 | M535NX3302A0 | NX3302-A | NX3302-A | NXView Touch Monitor | NXSTAGE MEDICAL, INC. | |
28 | M535NX1274A0 | NX1274-A | NXVIEW TOUCH SCREEN | NXSTAGE MEDICAL, INC. | ||
29 | M535NX12740 | NX1274 | NXVIEW TOUCH SCREEN | NXSTAGE MEDICAL, INC. | ||
30 | M535NX10005A0 | NX1000-5-A | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
31 | M535NX100050 | NX1000-5 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
32 | M535NX100040 | NX1000-4 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
33 | M535NX10003CAN0 | NX1000-3-CAN | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
34 | M535NX10003A0 | NX1000-3-A | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
35 | M535NX100030 | NX1000-3 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
36 | M535NX100020 | NX1000-2 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
37 | M535NX100016A0 | NX1000-16-A | VersiHD | NXSTAGE MEDICAL, INC. | ||
38 | M535NX1000160 | NX1000-16 | VersiHD | NXSTAGE MEDICAL, INC. | ||
39 | M535NX100010B0 | NX1000-10-B | VersiHD | NXSTAGE MEDICAL, INC. | ||
40 | M535NX100010A0 | NX1000-10-A | NXSTAGE SYSTEM ONE PLUS | NXSTAGE MEDICAL, INC. | ||
41 | M535NX1000100 | NX1000-10 | NSO PLUS, NXSTAGE SYSTEM ONE PLUS | NXSTAGE MEDICAL, INC. | ||
42 | M535NX100010 | NX1000-1 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
43 | M535FWS3080 | FWS-308 | EXPRESS FLUID WARMER DISPOSABLE | NXSTAGE MEDICAL, INC. | ||
44 | M535FWS3040 | FWS-304 | EXPRESS FLUID WARMER DISPOSABLE | NXSTAGE MEDICAL, INC. | ||
45 | M535FW300WW0 | FW-300-WW | EXPRESS FLUID WARMER | NXSTAGE MEDICAL, INC. | ||
46 | M535FW300A0 | FW-300-A | EXPRESS FLUID WARMER | NXSTAGE MEDICAL, INC. | ||
47 | M535FW30010 | FW-300-1 | EXPRESS FLUID WARMER ACCESSORIES | NXSTAGE MEDICAL, INC. | ||
48 | M535FW3000 | FW-300 | EXPRESS FLUID WARMER | NXSTAGE MEDICAL, INC. | ||
49 | M535CAR5350 | CAR-535 | NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP | NXSTAGE MEDICAL, INC. | ||
50 | M535CAR510C0 | CAR-510-C | NXSTAGE TPE CARTRIDGE | NXSTAGE MEDICAL, INC. |