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 | 08051736004178 | IBP4374 | CLEARUM HS 22 High Flux dialyzer | CLEARUM HS | BELLCO SRL | |
2 | 08051736004161 | IBP4373 | CLEARUM HS 20 High Flux dialyzer | CLEARUM HS | BELLCO SRL | |
3 | 08051736004154 | IBP4372 | CLEARUM HS 17 High Flux dialyzer | CLEARUM HS | BELLCO SRL | |
4 | 08051736004147 | IBP4371 | CLEARUM HS 15 High Flux dialyzer | CLEARUM HS | BELLCO SRL | |
5 | 08051736004130 | IBP4370 | CLEARUM HS 13 High Flux dialyzer | CLEARUM HS | BELLCO SRL | |
6 | 08033178233637 | 14 - HEMOCONCENTRATOR | SH | SORIN GROUP ITALIA SRL | ||
7 | 08033178102940 | 06 HEMOCONCENTRATOR | DHF | SORIN GROUP ITALIA SRL | ||
8 | 08033178102933 | 02 HEMOCONCENTRATOR | DHF | SORIN GROUP ITALIA SRL | ||
9 | 07332414126766 | 7.21 | 955792 | The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy. | PRISMAFLEX | GAMBRO AB |
10 | 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. | REVACLEAR | GAMBRO DIALYSATOREN GMBH |
11 | 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. | REVACLEAR | GAMBRO DIALYSATOREN GMBH |
12 | 07332414124519 | 955607 | 955607 | Intended for intermittant haemodialysis and/or isolated ultrafiltration treatmen Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body weight of 25 kg or more. To be used by trained operators in chronic care dialysis or hospital care environment. Not intended for Self-care or Home use. | AK 98 | GAMBRO AB |
13 | 07332414124236 | 7.20 | 955542 | The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy | Prismaflex | GAMBRO AB |
14 | 07332414124076 | 400 | 114746L | 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 | REVACLEAR | GAMBRO RENAL PRODUCTS, INC. |
15 | 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. | therMaxTherMax Blood Warmer | BAXTER HEALTHCARE CORPORATION |
16 | 07332414123055 | 300 | 114745L | Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and a Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis | REVACLEAR | GAMBRO RENAL PRODUCTS, INC. |
17 | 07332414119324 | 115463 | 115463 | 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. | Dual Lumen Extended Length Catheter and GALT insertion kit | GAMBRO UF SOLUTIONS, INC |
18 | 07332414117702 | 7.XX | 115269 | The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy | Prismaflex | GAMBRO AB |
19 | 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 | Revaclear | GAMBRO DIALYSATOREN GMBH |
20 | 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. | Revaclear | GAMBRO DIALYSATOREN GMBH |
21 | 07332414112387 | UF 500 | 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 | GAMBRO UF SOLUTIONS, INC |
22 | 07332414112370 | UF 500-HCT | 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 | GAMBRO UF SOLUTIONS, INC |
23 | 07332414112363 | 114153 | 114153 | 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. | Dual Lumen Extended Length Catheter | GAMBRO UF SOLUTIONS, INC |
24 | 07332414112301 | 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 | GAMBRO UF SOLUTIONS, INC |
25 | 07332414106126 | 113297 | 113297 | Exalis is an integrated product able to acquire, process and supply data require Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data | EXALIS | GAMBRO DASCO SPA |
26 | 07332414106119 | 6041909 | 6041909 | Exalis is an integrated product able to acquire, process and supply data require Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. | EXALIS | GAMBRO DASCO SPA |
27 | 07332414105266 | 5.XX | 113081 | The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy. | Prismaflex | GAMBRO AB |
28 | 07332414101701 | 110634 | 110634 | Revaclear-Revaclear Max are indicated for the treatment of chronic and acute ren Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis | POLYFLUX REVACLEAR MAX | GAMBRO RENAL PRODUCTS, INC. |
29 | 07332414101695 | 110633 | 110633 | Revaclear-Revaclear Max are indicated for the treatment of chronic and acute ren Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis | POLYFLUX REVACLEAR | GAMBRO RENAL PRODUCTS, INC. |
30 | 07332414090005 | M150 | 109990 | The Prismaflex M150 set is indicated for use only with the PrismaFlex control un The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. | PRISMAFLEX SET | GAMBRO INDUSTRIES |
31 | 07332414069315 | HF1400 | 107142 | The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system o The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. | PRISMAFLEX SET | GAMBRO INDUSTRIES |
32 | 07332414069254 | HF1000 | 107140 | The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system o The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. | PRISMAFLEX SET | GAMBRO INDUSTRIES |
33 | 07332414064556 | M100 | 106697 | The Prismaflex M100 set is indicated for use only with the PrismaFlex control un The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. | PRISMAFLEX SET | GAMBRO INDUSTRIES |
34 | 07332414064549 | M60 | 106696 | The Prismaflex M60 set is indicated for use only with the PrismaFlex control uni The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. | PRISMAFLEX SET | GAMBRO INDUSTRIES |
35 | 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 | POLYFLUX | GAMBRO DIALYSATOREN GMBH |
36 | 07332414042035 | 6023006700 | 103453 | Phoenix is a self-contained, microprocessor-controlled device that provides hemo Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies. | PHOENIX | GAMBRO DASCO SPA |
37 | 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 | POLYFLUX | GAMBRO DIALYSATOREN GMBH |
38 | 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 | POLYFLUX | GAMBRO DIALYSATOREN GMBH |
39 | 07332414036386 | 6H | 103403 | the Polyflux 6H is intended for chronic and acute applications in haemodialysis the Polyflux 6H is intended for chronic and acute applications in haemodialysis haemofiltration and hemofiltration on small patient including pediatric indication, considering blood flow, body weight and extracoporeal blood volume | Polyflux | GAMBRO DIALYSATOREN GMBH |
40 | 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 | POLYFLUX | GAMBRO DIALYSATOREN GMBH |
41 | 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 | POLYFLUX | GAMBRO DIALYSATOREN GMBH |
42 | 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 | POLYFLUX | GAMBRO DIALYSATOREN GMBH |
43 | 05060497260085 | SC-13940 | SC+ Hemodialysis Delivery Device | SC+ Hemodialysis Machine | QUANTA DIALYSIS TECHNOLOGIES LIMITED | |
44 | 05060497260047 | SC-14354 | SC+ Dialysate Cartridge | SC+ Dialysate Cartridge | QUANTA DIALYSIS TECHNOLOGIES LIMITED | |
45 | 04987671060006 | DBB-06 | The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use. | HEMODIALYSIS DELIVERY SYSTEM | NIKKISO CO.,LTD. | |
46 | 04987671041517 | DBB-06 | The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients only with acute or chronic renal failure. The DBB-06 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified, trained operator only. | HEMODIALYSIS DELIVERY SYSTEM | NIKKISO CO.,LTD. | |
47 | 04987350738417 | CX*HC11L | CAPIOX® HEMOCONCENTRATOR | TERUMO CORPORATION | ||
48 | 04987350738394 | CX*HC11S | CAPIOX® HEMOCONCENTRATOR | TERUMO CORPORATION | ||
49 | 04987350738356 | CX*HC05L | CAPIOX® HEMOCONCENTRATOR | TERUMO CORPORATION | ||
50 | 04987350738332 | CX*HC05S | CAPIOX® HEMOCONCENTRATOR | TERUMO CORPORATION |