No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00383790007245 | JD+03L2238-NIJ | 3mL Luer Lock with attached needle 22G x 1-1/2" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
2 | 00383790007238 | JD+03L2338-NIJ | 3mL Luer Lock with attached needle 23G x 1-1/2" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
3 | 00383790007221 | JD+03L2525-NIJ | 3mL Luer Lock with attached needle 25G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
4 | 00383790007214 | JD+03L2325-NIJ | 3mL Luer Lock with attached needle 23G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
5 | 00383790007207 | JD+03L2125-NIJ | 3mL Luer Lock with attached needle 21G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
6 | 00383790007191 | JD+03L2516-NIJ | 3mL Luer Lock with attached needle 25G x 5/8" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
7 | 00383790007184 | JD+03L2225-NIJ | 3mL Luer Lock with attached needle 22G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
8 | 00383790007177 | JD+03L2025-NIJ | 3mL Luer Lock with attached needle 20G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
9 | 00383790007139 | ELISIO™-25H | DD+ELISIO-25H | Surface area 2.5m² Max.TMP:66kPa(500mmHg) | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | NIPRO ELISIO™ -H HEMODIALYZER |
10 | 00383790007122 | ELISIO™-21H | DD+ELISIO-21H | Surface area 2.1m² Max.TMP:66kPa(500mmHg) | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | NIPRO ELISIO™ -H HEMODIALYZER |
11 | 00383790007115 | ELISIO™-19H | DD+ELISIO-19H | Surface area 1.9m² Max.TMP:66kPa(500mmHg) | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | NIPRO ELISIO™ -H HEMODIALYZER |
12 | 00383790007108 | ELISIO™-17H | DD+ELISIO-17H | Surface area 1.7m² Max.TMP:66kPa(500mmHg) | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | NIPRO ELISIO™ -H HEMODIALYZER |
13 | 00383790005944 | GU-NITRIXL-PF-US2K | Nitrile Examination Gloves, Size Extra Large | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
14 | 00383790005937 | GU-NITRILG-PF-US2K | Nitrile Examination Gloves, Size Large | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
15 | 00383790005920 | GU-NITRIMD-PF-US2K | Nitrile Examination Gloves, Size Medium | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
16 | 00383790008815 | MC+SDX01 | Hemodialysis System | KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 | Nipro SURDIAL DX Hemodialysis System | |
17 | 00383790009591 | NHP+88080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
18 | 00383790009577 | NHP+86080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
19 | 00383790009553 | NHP+84080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
20 | 00383790009492 | NHP+78080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
21 | 00383790009478 | NHP+76080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
22 | 00383790009454 | NHP+74080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
23 | 00383790005913 | GU-NITRISM-PF-US2K | Nitrile Examination Gloves, Size Small | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
24 | 00383790005906 | GU-NITRIXS-PF-US2K | Nitrile Examination Gloves, Size Extra Small | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
25 | 00383790005890 | GU-NITRILEXL-PF-US | Nitrile Examination Gloves, Size Extra Large | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
26 | 00383790005883 | GU-NITRILELG-PF-US | Nitrile Examination Gloves, Size Large | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
27 | 00383790005876 | GU-NITRILEMD-PF-US | Nitrile Examination Gloves, Size Medium | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
28 | 00383790005869 | GU-NITRILESM-PF-US | Nitrile Examination Gloves, Size Small | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
29 | 00383790005852 | GU-NITRILEXS-PF-US | Nitrile Examination Gloves, Size Extra Small | LZA | Polymer Patient Examination Glove | Nipro Nitrile Powder Free Examination Gloves | ||
30 | 00383790002240 | JD+01U3108-SB | JD+01U3108-SB | FMF | Syringe, Piston | 2 | NIPRO INSULIN SYRINGE | |
31 | 00383790009393 | NHP+68080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
32 | 00383790009379 | NHP+66080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
33 | 00383790009355 | NHP+64080 | OTW High Pressure Peripheral Balloon Catheter | LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | Cronus HP PTA Balloon Catheter | |
34 | 00383790008792 | JD+01U2913-SB | JD+01U2913-SB | FMF | Syringe, Piston | 2 | NIPRO INSULIN SYRINGE | |
35 | 00383790008785 | JD+01U3008-SB | JD+01U3008-SB | FMF | Syringe, Piston | 2 | NIPRO INSULIN SYRINGE | |
36 | 00383790008778 | JD+01U3013-SB | JD+01U3013-SB | FMF | Syringe, Piston | 2 | NIPRO INSULIN SYRINGE | |
37 | 00383790007368 | JD+03S-NIJ | 3mL without needle, Luer Slip tip | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
38 | 00383790007351 | JD+03L-NIJ | 3mL without needle, Luer lock tip | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
39 | 00383790007344 | JD+03S2325-NIJ | 3mL Luer Slip with attached needle 23G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
40 | 00383790007337 | JD+03S2125-NIJ | 3mL Luer Slip with attached needle 21G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
41 | 00383790007320 | JD+03S2025-NIJ | 3mL Luer Slip with attached needle 20G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
42 | 00383790007313 | JD+03S2516-NIJ | 3mL Luer Slip with attached needle 25G x 5/8" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
43 | 00383790007306 | JD+03S2225-NIJ | 3mL Luer Slip with attached needle 22G x 1" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
44 | 00383790007290 | JD+03S2219-NIJ | 3mL Luer Slip with attached needle 21G x 3/4" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
45 | 00383790007283 | JD+03L2332-NIJ | 3mL Luer Lock with attached needle 23G x 1-1/4" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
46 | 00383790007276 | JD+03L2138-NIJ | 3mL Luer Lock with attached needle 21G x 1-1/2" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
47 | 00383790007269 | JD+03L2538-NIJ | 3mL Luer Lock with attached needle 25G x 1-1/2" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
48 | 00383790007252 | JD+03L2038-NIJ | 3mL Luer Lock with attached needle 20G x 1-1/2" | FMF,FMI | Syringe, Piston,Needle, Hypodermic, Single Lumen | Nipro Syringe | ||
49 | 00383790007085 | ELISIO™-13H | DD+ELISIO-13H | Surface area 1.3m² Max.TMP:66kPa(500mmHg) | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | NIPRO ELISIO™ -H HEMODIALYZER |
50 | 00383790007078 | ELISIO™-11H | DD+ELISIO-11H | Surface area 1.1m² Max.TMP:66kPa(500mmHg) | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | NIPRO ELISIO™ -H HEMODIALYZER |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00383790008860 | CF+609N | Filter for clean dialysate and water | Nipro Ultrafilter | NIPRO MEDICAL CORPORATION | |
2 | 00383790008815 | MC+SDX01 | Hemodialysis System | Nipro SURDIAL DX Hemodialysis System | NIPRO MEDICAL CORPORATION | |
3 | 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 |
4 | 00383790008532 | ELISIO™-21M | DD+ELISIO-21M | Surface area 2.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
5 | 00383790008525 | ELISIO™-19M | DD+ELISIO-19M | Surface area 1.9m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
6 | 00383790008518 | ELISIO™-17M | DD+ELISIO-17M | Surface area 1.7m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
7 | 00383790008501 | ELISIO™-15M | DD+ELISIO-15M | Surface area 1.5m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
8 | 00383790008495 | ELISIO™-13M | DD+ELISIO-13M | Surface area 1.3m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
9 | 00383790008488 | ELISIO™-11M | DD+ELISIO-11M | Surface area 1.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -M HEMODIALYZER | NIPRO MEDICAL CORPORATION |
10 | 00383790007139 | ELISIO™-25H | DD+ELISIO-25H | Surface area 2.5m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
11 | 00383790007122 | ELISIO™-21H | DD+ELISIO-21H | Surface area 2.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
12 | 00383790007115 | ELISIO™-19H | DD+ELISIO-19H | Surface area 1.9m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
13 | 00383790007108 | ELISIO™-17H | DD+ELISIO-17H | Surface area 1.7m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
14 | 00383790007092 | ELISIO™-15H | DD+ELISIO-15H | Surface area 1.5m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
15 | 00383790007085 | ELISIO™-13H | DD+ELISIO-13H | Surface area 1.3m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
16 | 00383790007078 | ELISIO™-11H | DD+ELISIO-11H | Surface area 1.1m² Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
17 | 00383790007061 | ELISIO™-09H | DD+ELISIO-09H | Surface area 0.9m²Max.TMP:66kPa(500mmHg) | NIPRO ELISIO™ -H HEMODIALYZER | NIPRO MEDICAL CORPORATION |
18 | 00383790004411 | Cellentia™-21H | DD+CT21H | CELLULOSE TRIACETATE HEMODIALYZER2.1m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
19 | 00383790004404 | Cellentia™-19H | DD+CT19H | CELLULOSE TRIACETATE HEMODIALYZER1.9m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
20 | 00383790004398 | Cellentia™-17H | DD+CT17H | CELLULOSE TRIACETATE HEMODIALYZER1.7m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
21 | 00383790004381 | Cellentia™-15H | DD+CT15H | CELLULOSE TRIACETATE HEMODIALYZER1.5m² / Max.TMP 66kPa (500mmHg) | NIPRO Cellentia™-H Hemodialyzer | NIPRO MEDICAL CORPORATION |
22 | 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 |
23 | 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 |
24 | 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. |
25 | 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. |
26 | 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. |
27 | 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. |
28 | 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. |
29 | 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. |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 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. |
34 | 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 |
35 | 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 |
36 | 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 |
37 | 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 |
38 | 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 |
39 | 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 |
40 | 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 |
41 | 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 |
42 | 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 |
43 | 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 |
44 | 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 |
45 | 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 |
46 | 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. |
47 | 20850001011024 | PN-0000503 | ST-100 | Tablo Straws | OUTSET MEDICAL, INC. | |
48 | 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. |
49 | 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. |
50 | 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. |