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 | 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 |
11 | 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 |
12 | 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 |
13 | 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 |
14 | 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 |
15 | 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 |
16 | 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 |
17 | 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 |
18 | 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 |
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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00677964059148 | HF 1200 | Renaflo II Hemofilter | MEDIVATORS INC. | ||
2 | 00677964011252 | HPH 1400TS | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
3 | 00677964011245 | HPH 1000TS | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
4 | 00677964011238 | HPH 400TS | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
5 | 00677964011221 | HPH 1400 | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
6 | 00677964011214 | HPH 1000 | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
7 | 00677964011207 | HPH 400 | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
8 | 00677964011184 | HPH 700TS | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
9 | 00677964011177 | HPH 700 | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
10 | 00677964011115 | HPH Mini | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
11 | 00677964000867 | HPH Junior | High Performance Hemoconcentrator | Hemocor HPH | MEDIVATORS INC. | |
12 | 00677964000089 | HF 1200 | Renaflo II Hemofilter | MEDIVATORS INC. | ||
13 | 00677964000072 | HF 700 | Renaflo II Hemofilter | MEDIVATORS INC. | ||
14 | 00677964000065 | HF 400 | Renaflo II Hemofilter | MEDIVATORS INC. | ||
15 | 00383790008860 | CF+609N | Filter for clean dialysate and water | Nipro Ultrafilter | NIPRO MEDICAL CORPORATION | |
16 | 00383790008815 | MC+SDX01 | Hemodialysis System | Nipro SURDIAL DX Hemodialysis System | NIPRO MEDICAL CORPORATION | |
17 | 00383790008808 | A430/V912 | BL+A430/V912 | Blood Tubing Set for use with the SURDIAL DX Hemodialysis System | Nipro Set Blood Tubing Set | NIPRO MEDICAL CORPORATION |
18 | 00383790008532 | ELISIO™-21M | DD+ELISIO-21M | Surface area 2.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
19 | 00383790008525 | ELISIO™-19M | DD+ELISIO-19M | Surface area 1.9m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
20 | 00383790008518 | ELISIO™-17M | DD+ELISIO-17M | Surface area 1.7m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
21 | 00383790008501 | ELISIO™-15M | DD+ELISIO-15M | Surface area 1.5m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
22 | 00383790008495 | ELISIO™-13M | DD+ELISIO-13M | Surface area 1.3m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
23 | 00383790008488 | ELISIO™-11M | DD+ELISIO-11M | Surface area 1.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
24 | 00383790007139 | ELISIO™-25H | DD+ELISIO-25H | Surface area 2.5m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
25 | 00383790007122 | ELISIO™-21H | DD+ELISIO-21H | Surface area 2.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
26 | 00383790007115 | ELISIO™-19H | DD+ELISIO-19H | Surface area 1.9m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
27 | 00383790007108 | ELISIO™-17H | DD+ELISIO-17H | Surface area 1.7m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
28 | 00383790007092 | ELISIO™-15H | DD+ELISIO-15H | Surface area 1.5m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
29 | 00383790007085 | ELISIO™-13H | DD+ELISIO-13H | Surface area 1.3m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
30 | 00383790007078 | ELISIO™-11H | DD+ELISIO-11H | Surface area 1.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
31 | 00383790007061 | ELISIO™-09H | DD+ELISIO-09H | Surface area 0.9m²Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
32 | 00383790004411 | Cellentia™-21H | DD+CT21H | CELLULOSE TRIACETATE HEMODIALYZER2.1m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
33 | 00383790004404 | Cellentia™-19H | DD+CT19H | CELLULOSE TRIACETATE HEMODIALYZER1.9m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
34 | 00383790004398 | Cellentia™-17H | DD+CT17H | CELLULOSE TRIACETATE HEMODIALYZER1.7m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
35 | 00383790004381 | Cellentia™-15H | DD+CT15H | CELLULOSE TRIACETATE HEMODIALYZER1.5m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
36 | 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 |
37 | 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 |
38 | 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. |
39 | 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. |
40 | 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. |
41 | 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. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 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. |
46 | 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. |
47 | 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. |
48 | 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 |
49 | 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 |
50 | 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 |