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Dialyzer, High Permeability With Or Without Sealed Dialysate System

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Company Name
Description
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SAMI RRT
Spectral Medical Inc
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.
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SAMI RRT Cassette
Spectral Medical Inc
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.
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MARS TREATMENT KIT TYPE 1116/1 - X-MARS US
GAMBRO AB
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.
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MARS Monitor
GAMBRO AB
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.
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CLR
SEASTAR MEDICAL, INC.
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.
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Tablo Straws
OUTSET MEDICAL, INC.
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AquaFlexFlow UF 500 Plus - 24 Hr
Nuwellis Inc.
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.
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AquaFlexFlow UF 500
Nuwellis Inc.
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.
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AquaFlexFlow UF 500 Plus
Nuwellis Inc.
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.
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Aquadex SmartFlow Console
Nuwellis Inc.
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.
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Aquadex FlexFlow
Nuwellis Inc.
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.
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Blood Circuit Set
Nuwellis Inc.
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.
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Blood Circuit Set
Nuwellis Inc.
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.
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CLEARUM HS
BELLCO SRL
CLEARUM HS 22 High Flux dialyzer
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CLEARUM HS
BELLCO SRL
CLEARUM HS 20 High Flux dialyzer
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CLEARUM HS
BELLCO SRL
CLEARUM HS 17 High Flux dialyzer
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CLEARUM HS
BELLCO SRL
CLEARUM HS 15 High Flux dialyzer
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CLEARUM HS
BELLCO SRL
CLEARUM HS 13 High Flux dialyzer
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SH
SORIN GROUP ITALIA SRL
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DHF
SORIN GROUP ITALIA SRL
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DHF
SORIN GROUP ITALIA SRL
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PRISMAFLEX
GAMBRO AB
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
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REVACLEAR
Gambro Dialysatoren GmbH
Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis.
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REVACLEAR
Gambro Dialysatoren GmbH
Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis.
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AK 98
GAMBRO AB
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.
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Prismaflex
GAMBRO AB
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
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REVACLEAR
GAMBRO RENAL PRODUCTS, INC.
Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis
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therMaxTherMax Blood Warmer
BAXTER HEALTHCARE CORPORATION
The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.
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REVACLEAR
GAMBRO RENAL PRODUCTS, INC.
Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis
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Dual Lumen Extended Length Catheter and GALT insertion kit
GAMBRO UF SOLUTIONS, INC
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.
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Prismaflex
GAMBRO AB
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
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Revaclear
Gambro Dialysatoren GmbH
Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis
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Revaclear
Gambro Dialysatoren GmbH
Revaclear 300 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis.
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Blood Circuit Set
GAMBRO UF SOLUTIONS, INC
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.
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Blood Circuit Set
GAMBRO UF SOLUTIONS, INC
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.
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Dual Lumen Extended Length Catheter
GAMBRO UF SOLUTIONS, INC
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.
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Aquadex FlexFlow
GAMBRO UF SOLUTIONS, INC
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.
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EXALIS
GAMBRO DASCO SPA
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
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EXALIS
GAMBRO DASCO SPA
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.
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Prismaflex
GAMBRO AB
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
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POLYFLUX REVACLEAR MAX
GAMBRO RENAL PRODUCTS, INC.
Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
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POLYFLUX REVACLEAR
GAMBRO RENAL PRODUCTS, INC.
Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
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PRISMAFLEX SET
GAMBRO INDUSTRIES
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.
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PRISMAFLEX SET
GAMBRO INDUSTRIES
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.
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PRISMAFLEX SET
GAMBRO INDUSTRIES
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.
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PRISMAFLEX SET
GAMBRO INDUSTRIES
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.
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PRISMAFLEX SET
GAMBRO INDUSTRIES
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.
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POLYFLUX
Gambro Dialysatoren GmbH
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
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PHOENIX
GAMBRO DASCO SPA
Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.
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POLYFLUX
Gambro Dialysatoren GmbH
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