No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00085412730882 | 2C0430 | 2C0430 | Three Lead Parenteral Nutrition Transfer Set | NEP | System/device, pharmacy compounding | 2 | NA |
2 | 00085412676647 | 2R8538 | 2R8538 | CLEARLINK System Solution Set with DUO-VENT Spike | FPA | Set, Administration, Intravascular | 2 | CLEARLINK/CONTINU-FLO/DUO-VENT |
3 | 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 | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | prisMaxPrisMax System |
4 | 00085412624839 | ADS201816 | ADS201816 | 13cm Malleable Applicator Tip | KGZ | ACCESSORIES, CATHETER | NA | |
5 | 00085412624822 | ADS201815 | ADS201815 | DISPOSABLE CURVED APPLICATOR | KYZ | SYRINGE, IRRIGATING (NON DENTAL) | NA | |
6 | 00085412025360 | 5C4527 | 5C4527 | The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilit The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilitate peritoneal dialysis set connector insertion into and removal from, Peritoneal Dialysis Solution in plastic container. | FKK | CLAMP, LINE | 1 | NA |
7 | 25413765545720 | 5CGM01 | 5CGM01 | Sharesource is a web-based connectivity platform that allows authorized users, i Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Claria APD System. | FKX | System, peritoneal, automatic delivery | 2 | Sharesource |
8 | 15413765545723 | 5CGM01 | 5CGM01 | Sharesource is a web-based connectivity platform that allows authorized users, i Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Claria APD System. | FKX | System, peritoneal, automatic delivery | 2 | Sharesource |
9 | 05413765482595 | H93849 | H93849 | Admix Dispensing Pin | LHI,FMF | Set, i.V. Fluid transfer,Syringe, piston | 2 | NA |
10 | 05413765404634 | 934072 | 934072 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant |
11 | 05413765404627 | 934071 | 934071 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant |
12 | 05413765404610 | 934070 | 934070 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant |
13 | 00085412639345 | 2N3358 | 2N3358 | Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
14 | 00085412660387 | 2N3386 | 2N3386 | Micro-Volume Catheter Extension Set with 0.2 micrometer Filter | FPA,FPB | Set, administration, intravascular,Filter, infusion line | 2 | EXTENSION SET |
15 | 00085412653303 | 2N3383 | 2N3383 | Blood Extension Set | BRZ | Set, blood transfusion | 2 | EXTENSION SET |
16 | 00085412653297 | 2N3382 | 2N3382 | Micro-Volume Extension Set with 0.2 m Filter | FPA,FPB | Set, administration, intravascular,Filter, infusion line | 2 | EXTENSION SET |
17 | 00085412653280 | 2N3380 | 2N3380 | Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
18 | 00085412639406 | 2N3363 | 2N3363 | Light Resistant Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
19 | 00085412639390 | 2N3362 | 2N3362 | Polyethylene Lined Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
20 | 00085412639383 | 2N3361 | 2N3361 | Polyethylene Lined Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
21 | 00085412639369 | 2N3360 | 2N3360 | Polyethylene Lined Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
22 | 00085412639352 | 2N3359 | 2N3359 | Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
23 | 00085412639338 | 2N3357 | 2N3357 | Micro-Volume Extension Set with 0.2 Micrometer Filter | FPA,FPB | Set, administration, intravascular,Filter, infusion line | 2 | EXTENSION SET |
24 | 00085412639321 | 2N3356 | 2N3356 | Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
25 | 00085412638843 | 2N3355 | 2N3355 | Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
26 | 00085412638836 | 2N3354 | 2N3354 | Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
27 | 00085412095165 | 1503188 | 1503188 | GELFOAM® PLUS - POWDER is an implantable hemostat supplied as a ready to use med GELFOAM® PLUS - POWDER is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® absorbable gelatin powder, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device | LMF | Agent, absorbable hemostatic, collagen based | 3 | Gelfoam Plus |
28 | 00085412095158 | 1503187 | 1503187 | GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Compressed Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device | LMF | Agent, absorbable hemostatic, collagen based | 3 | Gelfoam Plus |
29 | 00085412091006 | 1502186 | 1502186 | The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostatic Matrix. | LMF | Agent, Absorbable Hemostatic, Collagen Based | 3 | Floseal Special Applicator Tips |
30 | 00085412086309 | 1501341 | 1501341 | GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical devic GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device | LMF | Agent, Absorbable Hemostatic, Collagen Based | 3 | Gelfoam Plus |
31 | 00085412070643 | 5C4957 | 5C4957 | UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag C UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container or any Baxter Y-Set. The clamp is specifically designed to assist individuals who experience difficulty in operating other ancillary clamps or pre-attached clamps. | FKK | CLAMP, LINE | 1 | ULTRACLAMP |
32 | 05413765586118 | ADS201897 | ADS201897 | The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe. | GCJ | Laparoscope, general & plastic surgery | 2 | EASYGRIP FLO-41 |
33 | 00085412680743 | 2C0427 | 2C0427 | Solution Transfer Set with DUO-VENT Spike. Large Bore Tubing and Needle Adapter 26 | NEP | System/device, pharmacy compounding | 2 | SOLUTION SET |
34 | 00085412653631 | 2C8554 | 2C8554 | Male Luer Lock Adapter with Retractable Collar | FPA | Set, administration, intravascular | 2 | SOLUTION SET |
35 | 00085412565705 | 2R8864 | 2R8864 | Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar | FPA | Set, administration, intravascular | 2 | CLEARLINK/BURETROL |
36 | 00085412083339 | 934034 | 934034 | The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components. | NBE | Sealant,Polymerizing | Coseal Surgical Sealant Extended Applicator | |
37 | 07332414123932 | 955516 | 955516 | The Blood Warmer Disposable is a disposable circuit for use with the TherMax blo The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets. | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | therMaxTherMax Blood Warmer |
38 | 00085412827957 | ADS202105 | ADS202105 | Floseal with Recothrom - 5mL | PMX | Absorbable collagen hemostatic agent with thrombin | FLOSEAL HEMOSTATIC MATRIX | |
39 | 00085412656304 | ADS201883 | ADS201883 | Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | FLOSEAL HEMOSTATIC MATRIX |
40 | 00085412639604 | ADS201845 | ADS201845 | FLOSEAL Hemostatic Matrix, 10mL | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | FLOSEAL HEMOSTATIC MATRIX |
41 | 00085412639598 | ADS201844 | ADS201844 | FLOSEAL Hemostatic Matrix, 5ml | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | FLOSEAL HEMOSTATIC MATRIX |
42 | 00085412532868 | 1505291 | 1505291 | FLOSEAL Hemostatic Matrix, 10 mL | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | Floseal |
43 | 00085412532738 | 1505288 | 1505288 | FLOSEAL Hemostatic Matrix, 5 mL | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | Floseal |
44 | 00085412083322 | 934033 | 934033 | The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components. | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant Replacement Applicator |
45 | 00085412050829 | 5C4136 | 5C4136 | This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 mm (0.150 inch) ID tubing and a flanged Easy-Lock Connector. This device is indicated for the personal cycler peritoneal dialysis system used for automatic control of dialysate solution exchanges in the treatment of renal failure patients undergoing peritoneal dialysis. | FKX | System, peritoneal, automatic delivery | 2 | Easy-Lock |
46 | 05413765577369 | 83003393 | 83003393 | ABACUS 3.3 ME | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
47 | 05413765577352 | 83003392 | 83003392 | ABACUS 3.3 SE | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
48 | 05413765577345 | 83003391 | 83003391 | ABACUS 3.3 CE | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
49 | 05413765577321 | 83003390 | 83003390 | ABACUS 3.3 DE | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
50 | 00085412722894 | 5C4145NS | 5C4145NS | The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Baxter Automated Peritoneal Dialysis (APD) Cycler Tubing Sets. | KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | Cycler Drainage Bag |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 |
2 | 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 |
3 | 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 |
4 | 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 |
5 | 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 |
6 | 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 |
7 | 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 |
8 | 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 |
9 | 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 |
10 | 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 |
11 | 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 |
12 | 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 |
13 | 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. |
14 | 20850001011024 | PN-0000503 | ST-100 | Tablo Straws | OUTSET MEDICAL, INC. | |
15 | 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. |
16 | 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. |
17 | 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. |
18 | 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. |
19 | 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. |
20 | 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. |
21 | 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. |
22 | M535SSK5350 | SSK-535 | NXSTAGE SPEEDSWAP EXPRESS KIT | NXSTAGE MEDICAL, INC. | ||
23 | M535SLE3011M30980 | SLE-3011M3098 | Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | MEDISYSTEMS CORPORATION | ||
24 | M535SLE3010M30960 | SLE-3010M3096 | Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | MEDISYSTEMS CORPORATION | ||
25 | M535SLE3000M30950 | SLE-3000M3095 | Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri | MEDISYSTEMS CORPORATION | ||
26 | M535NX3302A0 | NX3302-A | NX3302-A | NXView Touch Monitor | NXSTAGE MEDICAL, INC. | |
27 | M535NX1274A0 | NX1274-A | NXVIEW TOUCH SCREEN | NXSTAGE MEDICAL, INC. | ||
28 | M535NX12740 | NX1274 | NXVIEW TOUCH SCREEN | NXSTAGE MEDICAL, INC. | ||
29 | M535NX10005A0 | NX1000-5-A | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
30 | M535NX100050 | NX1000-5 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
31 | M535NX100040 | NX1000-4 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
32 | M535NX10003CAN0 | NX1000-3-CAN | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
33 | M535NX10003A0 | NX1000-3-A | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
34 | M535NX100030 | NX1000-3 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
35 | M535NX100020 | NX1000-2 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
36 | M535NX100016A0 | NX1000-16-A | VersiHD | NXSTAGE MEDICAL, INC. | ||
37 | M535NX1000160 | NX1000-16 | VersiHD | NXSTAGE MEDICAL, INC. | ||
38 | M535NX100010B0 | NX1000-10-B | VersiHD | NXSTAGE MEDICAL, INC. | ||
39 | M535NX100010A0 | NX1000-10-A | NXSTAGE SYSTEM ONE PLUS | NXSTAGE MEDICAL, INC. | ||
40 | M535NX1000100 | NX1000-10 | NSO PLUS, NXSTAGE SYSTEM ONE PLUS | NXSTAGE MEDICAL, INC. | ||
41 | M535NX100010 | NX1000-1 | NXSTAGE SYSTEM ONE | NXSTAGE MEDICAL, INC. | ||
42 | M535FWS3080 | FWS-308 | EXPRESS FLUID WARMER DISPOSABLE | NXSTAGE MEDICAL, INC. | ||
43 | M535FWS3040 | FWS-304 | EXPRESS FLUID WARMER DISPOSABLE | NXSTAGE MEDICAL, INC. | ||
44 | M535FW300WW0 | FW-300-WW | EXPRESS FLUID WARMER | NXSTAGE MEDICAL, INC. | ||
45 | M535FW300A0 | FW-300-A | EXPRESS FLUID WARMER | NXSTAGE MEDICAL, INC. | ||
46 | M535FW30010 | FW-300-1 | EXPRESS FLUID WARMER ACCESSORIES | NXSTAGE MEDICAL, INC. | ||
47 | M535FW3000 | FW-300 | EXPRESS FLUID WARMER | NXSTAGE MEDICAL, INC. | ||
48 | M535CAR5350 | CAR-535 | NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP | NXSTAGE MEDICAL, INC. | ||
49 | M535CAR510C0 | CAR-510-C | NXSTAGE TPE CARTRIDGE | NXSTAGE MEDICAL, INC. | ||
50 | M535CAR510B0 | CAR-510-B | NXSTAGE TPE CARTRIDGE | NXSTAGE MEDICAL, INC. |