No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840861102037 | 026-20226A | 026-20226A | KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | Cycler Drain Bag Set | ||
2 | 00840861101962 | 08-4400-1 | 08-4400-1 | NaturaLyte Dry Pack Sodium Bicarbonate, Carton | KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 2 | NaturaLyte |
3 | 00840861101955 | 08-4112-2 | 08-4112-2 | NaturaLyte Dry Pack Sodium Bicarbonate RX 12 | KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 2 | NaturaLyte |
4 | 00840861101948 | 08-4110-6 | 08-4110-6 | NaturaLyte Dry Pack Sodium Bicarbonate RX 10 | KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 2 | NaturaLyte |
5 | 00840861101931 | 08-4000-LB 6.4L | 08-4000-LB | NaturaLyte Liquid Sodium Bicarbonate, Case | KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 2 | NaturaLyte |
6 | 00840861100811 | 050-95018 | APD Luer-Lock Adapter | KDJ | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | 2 | Safe-Lock® | |
7 | 00840861100705 | 050-75000 | Safe-Lock® Catheter Adapter Co-Pack Type II | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Safe-Lock® | |
8 | 00840861100668 | 050-30026 | Safe-Lock® Universal Connector | KDJ | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | 2 | Safe-Lock® | |
9 | 00840861100651 | 050-30024 | Safe-Lock® Catheter Adapter Sealing Cap | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Safe-Lock® | |
10 | 00840861100224 | 03-2621-5 | 03-2621-5 | Post-pump, 8.0 mm | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
11 | 00840861100477 | 03-2795-7 | 03-2795-7 | Pre-pump, 8.0 mm, BVM | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
12 | 00840861100330 | 03-2962-3 | 03-2962-3 | Pre-pump, 8.0 mm, Home Hemo with prime bag | ONW | Hemodialysis system for home use | 2 | CombiSet |
13 | 00840861100323 | 03-2922-7 | 03-2922-7 | Pre-pump, 8.0 mm | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
14 | 00840861100309 | 03-2742-9 | 03-2742-9 | Pre-pump, 8.0 mm | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
15 | 00840861100293 | 03-2722-9 | 03-2722-9 | Pre-pump, 8.0 mm | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
16 | 00840861100286 | 03-2696-7 | 03-2696-7 | 8.0 mm, single needle | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
17 | 00840861100262 | 03-2692-6 | 03-2692-6 | Pre-pump, 6.35 mm, low volume | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
18 | 00840861100255 | 03-2631-4 | 03-2631-4 | Post-pump, 6.35 mm | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
19 | 00840861100248 | 03-2630-6 | 03-2630-6 | Pre-pump, 6.35 mm | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
20 | 00840861100231 | 03-2622-3 | 03-2622-3 | Pre-pump, 8.0 mm | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 2 | CombiSet |
21 | 00840861100170 | 0500325E | F250NR Optiflux Dialyzer / High Flux / Polysulfone / 2.5 m2 / Ebeam / Single Use / 142 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
22 | 00840861100163 | 0500320E | F200NR Optiflux Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 113 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
23 | 00840861100156 | 0500318E | F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / Ebeam / Single Use / 102 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
24 | 00840861100149 | 0500316E | F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL | FJI | DIALYZER, CAPILLARY, HOLLOW FIBER | 2 | Optiflux® | |
25 | 00840861100132 | 0500320N | F200NR Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Single Use / 113 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
26 | 00840861100125 | 0500318N | F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / ETO / Single Use / 97 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
27 | 00840861100101 | 0500320A | F200A Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Multiple Use / 113 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
28 | 00840861100095 | 0500318A | F180A Optiflux Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 99 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
29 | 00840861100088 | 0500308E | F18NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.8 m2 / Ebeam / Single Use / 103 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | Optiflux® | ||
30 | 00840861100071 | 0500306E | F16NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 84 mL | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | Optiflux® | |
31 | 10840861100825 | 04-9100-1 | 04-9100-1 | Bloodline Connector Clip. For CombiSet Bloodlines only | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Fresenius HemaClip | |
32 | 00840861101320 | 08-4080-BB | 08-4080-BB | Bibag Dry Sodium Bicarbonate | KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 2 | Bibag |
33 | 00840861101313 | 08-4078-BB | 08-4078-BB | Bibag Dry Sodium Bicarbonate | KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 2 | Bibag |
34 | 00840861100682 | 050-30035 | Premier Safe-Lock® Transfer Set - 8 inch | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Premier | |
35 | 00840861100675 | 050-30034 | PREMIER LUER-LOCK Transfer Set - 8 inch | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Premier | |
36 | 00840861100064 | 0500154A | F80A Hemoflow Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL | MSF | HEMODIALYZER, RE-USE, HIGH FLUX | 2 | Hemoflow™ | |
37 | 00840861100057 | 0500136A | F60A Hemoflow Dialyzer / High Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL | MSF | HEMODIALYZER, RE-USE, HIGH FLUX | 2 | Hemoflow™ | |
38 | 00840861100040 | 0500164A | F8 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL | FJI | DIALYZER, CAPILLARY, HOLLOW FIBER | 2 | Hemoflow™ | |
39 | 00840861100033 | 0500145A | F6 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL | FJI | DIALYZER, CAPILLARY, HOLLOW FIBER | 2 | Hemoflow™ | |
40 | 00840861100026 | 0520161A | F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Sing F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Single Use / 45 mL | FJI | DIALYZER, CAPILLARY, HOLLOW FIBER | 2 | Hemoflow™ | |
41 | 00840861100019 | 0520165A | F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.3 m2 / ETO / Low Volume / Sing F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.3 m2 / ETO / Low Volume / Single Use / 26 mL | FJI | DIALYZER, CAPILLARY, HOLLOW FIBER | 2 | Hemoflow™ | |
42 | 00840861101115 | 026-20036A | 026-20036A | Liberty® Drain Line | FKX | System, Peritoneal, Automatic Delivery | 2 | Liberty® |
43 | 00840861100750 | 050-87216 | 050-87216 | Liberty Cycler Set, One patient connector with extended patient and drain lines | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Liberty® |
44 | 00840861100743 | 050-87215 | 050-87215 | Liberty® Cycler Set with Single stay.safe® PIN Connector | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Liberty® |
45 | 00840861100736 | 050-87212 | 050-87212 | Liberty® Cycler Set with Dual stay.safe® PIN Connector | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Liberty® |
46 | 00840861100620 | 026-20226 | 026-20226 | Liberty® Drain Set | FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 2 | Liberty® |
47 | 00840861100491 | 04-7103-7 | 04-7103-7 | 2008 MeDS Pump Tubing Set | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | MeDS Pump |
48 | 00840861100316 | 03-2794-0 | 03-2794-0 | Pre-pump, 8.0 mm, with Twister® Reverse Access Flow Device | KOC | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS | 2 | CombiSet Twister |
49 | 00840861102327 | 030-10810-1 | FKX | System, Peritoneal, Automatic Delivery | 2 | stay•safe® Handi-tool | ||
50 | 00840861100415 | 0342501 | 0342501 | FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | CAREline |
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 | 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 |
24 | 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 |
25 | 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. |
26 | 20850001011024 | PN-0000503 | ST-100 | Tablo Straws | OUTSET MEDICAL, INC. | |
27 | 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. |
28 | 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. |
29 | 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. |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 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. |
34 | M535SSK5350 | SSK-535 | NXSTAGE SPEEDSWAP EXPRESS KIT | NXSTAGE MEDICAL, INC. | ||
35 | M535SLE3011M30980 | SLE-3011M3098 | Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | MEDISYSTEMS CORPORATION | ||
36 | M535SLE3010M30960 | SLE-3010M3096 | Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | MEDISYSTEMS CORPORATION | ||
37 | M535SLE3000M30950 | SLE-3000M3095 | Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri | MEDISYSTEMS CORPORATION | ||
38 | M535NX3302A0 | NX3302-A | NX3302-A | NXView Touch Monitor | NXSTAGE MEDICAL, INC. | |
39 | M535NX1274A0 | NX1274-A | NXVIEW TOUCH SCREEN | NXSTAGE MEDICAL, INC. | ||
40 | M535NX12740 | NX1274 | NXVIEW TOUCH SCREEN | NXSTAGE MEDICAL, INC. | ||
41 | M535NX10005A0 | NX1000-5-A | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
42 | M535NX100050 | NX1000-5 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
43 | M535NX100040 | NX1000-4 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
44 | M535NX10003CAN0 | NX1000-3-CAN | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
45 | M535NX10003A0 | NX1000-3-A | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
46 | M535NX100030 | NX1000-3 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
47 | M535NX100020 | NX1000-2 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
48 | M535NX100016A0 | NX1000-16-A | VersiHD | NXSTAGE MEDICAL, INC. | ||
49 | M535NX1000160 | NX1000-16 | VersiHD | NXSTAGE MEDICAL, INC. | ||
50 | M535NX100010B0 | NX1000-10-B | VersiHD | NXSTAGE MEDICAL, INC. |