Important Safety Information
Vantive, formerly the Baxter Kidney Care segment, is currently transitioning products to the new organisation and from the EU Medical Device Directive (MDD) to the new EU Medical Device Regulation (MDR). During this transition period you will find product safety information below covering products in two different states MDD or MDR (where applicable).
Theranova
MDD
Intended purpose: Theranova dialyzers are indicated for the treatment of chronic renal failure by hemodialysis. Do not use Theranova dialyzers for hemodiafiltration (HDF) or hemofiltration (HF) therapy. Do not apply isolated ultrafiltration when using Theranova dialyzers.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal manufacturer: Gambro Dialysatoren GmbH, Hechingen, Germany.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: December 2024.
MDR
Intended purpose: Theranova hemodialyzers are intended to purify blood in hemodialysis.
CAUTION! Do not use Theranova devices for HDF (hemodiafiltration) or HF (hemofiltration) due to higher permeability of larger molecular weight proteins such as albumin.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: December 2024.
Polyflux H
MDD
Intended purpose: Polyflux H capillary dialyzer/filter is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatment of chronic or acute renal failure.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal manufacturer: Gambro Dialysatoren GmbH, Hechingen, Germany.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: July 2025.
MDR
Intended purpose: Polyflux H hemodialyzers/diafilters/filters are intented to purify blood in hemodialysis, hemodiafiltration and hemofiltration.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025
Polyflux L
MDD
Intended purpose: Polyflux L capillary dialyzer/filter is intended for use in hemodialysis for the treatment of chronic or acute renal failure.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal manufacturer: Gambro Dialysatoren GmbH, Hechingen, Germany.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: May 2025.
MDR
Intended purpose: Polyflux L hemodialyzers are intended to purify blood in hemodialysis.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025
Polyflux 2H
MDD
Intended purpose: the Polyflux 2H dialyzer is intended to be used for the treatment of chronic or acute renal failure by hemodialysis, hemodiafiltration and hemofiltration.
In consideration of extracorporeal blood volume, blood flow and body weight, the Polyflux 2H/6H dialyzer can be used for low weight patients.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal manufacturer: Gambro Dialysatoren GmbH, Hechingen, Germany.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025.
MDR
Intended purpose: Polyflux 2H hemodialyzers/diafilters/filters are intended to purify blood in hemodialysis, hemodiafiltration and hemofiltration.
Polyflux 2H/6H devices are indicated for the treatment of chronic or acute renal failure. In consideration of extracorporeal blood volume, blood flow, performance and body weight, the Polyflux 2H/6H can be used for low weight patients.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025
Polyflux 6H
MDD
Intended purpose: Polyflux 6H is intended for chronic and acute applications in hemodialysis, hemodiafiltration and hemofiltration on small patients including pediatric indications, considering blood flow, body weight and extracorporeal volume.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal manufacturer: Gambro Dialysatoren GmbH, Hechingen, Germany.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025.
MDR
Intended purpose: Polyflux 6H devices are indicated for the treatment of chronic and acute renal failure. In consideration of extracorporeal blood volume, blood flow, performance and body weight, the Polyflux 6H can be used for low weight patients.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025
Revaclear
MDD
Intended purpose: Revaclear 300, Revaclear 400 and Revaclear 500 dialyzers are indicated for treatment of chronic & acute renal failure by hemodialysis or hemodiafiltration dialyzers.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal manufacturer: Gambro Dialysatoren GmbH, Hechingen, Germany.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025.
MDR
Intended purpose: Revaclear hemodialyzers/diafilters are intended to purify blood in hemodialysis and hemodiafiltration.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: May 2025.
Nephral ST
MDR
Intended purpose: Nephral ST hemodialyzers/diafilters/filters are intended to purify blood in hemodialysis, hemodiafiltration and hemofiltration.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025
Evodial
MDR
Intended purpose: Evodial hemodialyzers/diafilters/filters are intended to purify blood in hemodialysis, hemodiafiltration and hemofiltration.
Medical devices of class III.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: February 2026.
Theralite
MDD
Intended purpose: Theralite dialyzer is only intended to be used for blood purification in hemodialysis mode in diseases where removal of plasma components with molecular weights up to a value of 45 kDa is indicated.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal manufacturer: Gambro Dialysatoren GmbH, Hechingen, Germany.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: May 2025.
MDR
Intended purpose: Theralite hemodialyzers are intended to purify blood in hemodialysis.
Theralite 2100 devices are indicated for patients suffering from acute renal impairment requiring dialysis for removal of plasma components up to 45 KDa in the context of myeloma cast nephropathy or rhabdomyolysis.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: July 2025
BiCart
MDR
Intended purpose: The BiCart product is intended for preparation of hemodialysis solutions. The BiCart cartridge is also intended for preparation of hemodiafiltration and hemofiltration substitution fluids. The BiCart product must always be used together with a suitable acid concentrate.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: December 2024.
CleanCart A
MDR
Intended purpose: The CleanCart A cartridge is intended for a preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins, from the dialysis machine's fluid circuit. The CleanCart A must be used in combination with the heat disinfection program of the corresponding dialysis machine.
Medical device of class I.
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: August 2025
CleanCart C
MDR
Intended purpose: The CleanCart C cartridge is intended for a preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit. The CleanCart C must be used in combination with the heat disinfection program of the corresponding dialysis machine.
Medical device of class I.
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2025
SoftPac Citrate
MDR
Intended purpose: The SoftPac Citrate product is intended to be used as a citrate-based acid concentrate together with a dry sodium bicarbonate cartridge for on-line preparation of hemodialysis, hemodiafiltration or hemofiltration fluids on compatible Vantive/Baxter/Gambro dialysis systems.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2025.
SelectBag Citrate
MDR
Intended purpose: The SelectBag Citrate product is intended to be used as a citric acid-based concentrate together with the BiCart cartridge for on-line preparation of hemodialysis, hemodiafiltration and hemofiltration fluids on compatible Baxter/Gambro dialysis systems.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: March 2025
BiCart Select combi-pak
MDR
Intended purpose: the BiCart and SelectBag products are intended for preparation of hemodialysis solutions and, when used on compatible Baxter/Gambro dialysis systems, hemodiafiltration and hemofiltration substitution fluids. The BiCart and SelectCart products must always be used together with a suitable acid component concentrate.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: March 2025
Artis Physio
MDD
Intended purpose: The Artis Dialysis System is intended to perform intermittent Hemodialysis (HD), Hemofiltration (HF) and Hemodiafiltration (HDF) therapies. The Artis Dialysis System is intended to treat patients with chronic or acute renal failure upon prescription by a physician. The Artis Dialysis System is intended to be used by trained operators in chronic dialysis facilities and Limited Care Centers.
Medical devices of class IIb.
Notified body: BSI (CE 2797).
Legal manufacturer: Gambro Dasco S.p.A, Italy.
Refer to the user manual for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: July 2016.
Artis Physio Plus
MDD
Intended purpose: The Artis Dialysis System is intended to perform intermittent Hemodialysis (HD), Hemofiltration (HF) and Hemodiafiltration (HDF) therapies. The Artis Dialysis System is intended to treat patients with chronic or acute renal failure upon prescription by a physician. The Artis Dialysis System is intended to be used by trained operators in chronic dialysis facilities and Limited Care Centers.
Medical devices of class IIb.
Notified body: BSI (CE 2797).
Legal manufacturer: Gambro Dasco S.p.A, Italy.
Refer to the user manual for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: October 2018
AK98
MDD
Intended purpose: Hemodialysis system intended to perform intermittent Hemodialysis (HD).
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Gambro Lundia AB, Sweden.
Refer to the user manual for safe and proper use.
Date of preparation: August 2025
MDR
Intended purpose: The AK98 machine is intended to perform hemodialysis (HD). The AK98 machine is intended to treat patients with chronic renal failure upon prescription by physician.
Medical devices of Class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the user manual for safe and proper use.
Date of preparation : January 2025
Artiset bloodlines
MDR
Intended purpose: ArtiSet PrePost is a single use sterile medical device (blood tubing system) intended to be used as an extracorporeal blood circuit for double needle Hemodialysis, Hemodiafiltration and Hemofiltration treatments on Artis/Evosys system. If connected to the proper accessories, it can be used to perform Hemodiafiltration and Hemofiltration treatments in pre or postdilution configuration, together with priming, bolus, rinseback, with substitution and infusion fluid on-line produced by the dialysis machine and filtered by a single use membrane designed for retention of bacteria and endotoxins.
Medical device class of class IIb.
Notified body: TÜV SÜD (CE 0123)
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Please read the instructions and warnings carefully before using these products.
Date of preparation: October 2025
Homechoice Claria
MDD
Intended purpose: Baxter’s Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the home healthcare environment including comparable use in professional healthcare facilities.
Device class: IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, 8010 Zurich, Switzerland.
Refer to the user manual for safe and proper use.
Date of preparation: October 2025
MDR (1st July 2026)
Intended purpose: Homechoice Claria APD system is intended for Automated Peritoneal Dialysis therapy for treating patients with end-stage renal disease in clinical and home settings.
Device class: IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the user manual for safe and proper use.
Date of preparation: October 2025
Sharesource Claria
MDD
Intended purpose: The Sharesource portal is intended for use by healthcare professionals to remotely communicate with compatible dialysis instruments and transfer data to a central database to aid in the review, analysis, and evaluation of patients’ historical treatment results. This system is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways.
Device class: IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, 8010 Zurich, Switzerland.
Refer to the user manual for safe and proper use.
Date of preparation: October 2025
MDR (1st July 2026)
Intended purpose: Sharesource Claria is intended to remotely communicate, monitor, and manage treatment parameters from compatible dialysis instruments used for patients undergoing Peritoneal dialysis.
Device class: IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the user manual for safe and proper use.
Date of preparation: October 2025
Sharesource Adequest
MDR
Intended purpose: Sharesource Adequest is a stand-alone software application used by healthcare professionals to calculate solute clearances and net fluid removal for individual patients undergoing peritoneal dialysis based on therapy parameters provided by the clinician, thus eliminating the need for the clinician to perform manual calculations. These equations are obtained from published literature based on the patient’s age, gender, and body habitus. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Device class: IIa.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, Glattpark, Switzerland.
Refer to the user manual for safe and proper use.
Date of preparation: October 2025
MDR (1st July 2026)
Intended purpose: Sharesource Adequest is a stand-alone software application used by healthcare professionals to calculate solute clearances and net fluid removal for individual patients undergoing peritoneal dialysis based on therapy parameters provided by the clinician, thus eliminating the need for the clinician to perform manual calculations. These equations are obtained from published literature based on the patient’s age, gender, and body habitus. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Device class: IIa.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the user manual for safe and proper use.
Date of preparation: October 2025
Prismaflex
M and ST sets
MDD
Intended purpose: The Prismaflex set is indicated for use only with the PrismaFlex control unit or with the PrisMax contral 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. This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
Medical devices of class IIb.
Notified body: BSI NL (CE 2797).
Legal Manufacturer: Gambro Industries, Meyzieu, France.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
MDR
Intended purpose: The Prismaflex M and ST sets are single use devices that provides blood purification through a semi-permeable membrane. These sets are for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
Medical devices of class IIb.
Notified body. TÜV SÜD (CE 0123).
Legal Manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Prismaflex
HF20 set
MDD
Intended purpose: The set is indicated for use only with the Prismaflex control unit or with 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.
Medical devices of class IIb.
Notified body: BSI NL (CE 2797).
Legal Manufacturer: Gambro Industries, Meyzieu, France.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Prismaflex
HF 1000 set
HF 1400 set
MDD
Intended use / indications: The Prismaflex set is indicated for use only with the PrismaFlex system or with 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. This set is intended for use in the following veno-venous therapies: SCUF ; CVVH ; CVVHD ; CVVHDF. All treatments administered via the Prismaflex set must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment. The Prismaflex HF1000/HF1400 sets should be restricted to patients with a body weight greater than 30kg (66lb).
Medical devices of class IIb.
Notified body: BSI NL (CE 2797).
Legal Manufacturer: Gambro Industries SAS, Meyzieu, France.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Prismaflex
HP-X set
MDD
Intended use: The Prismaflex HP-X set is a set of blood lines intended for extracorporeal circulation of blood on the control unit and designed to be connected to blood purification devices. Refer to the table in section “Instructions for use” and to control unit operator’s manual to ensure the compatibility of the chosen blood purification device. Strict adherence to the set instructions for use and to control unit operator’s manual is required.
Indications: Refer to the instructions for use of the chosen blood purification device for possible indications and contraindications. All treatments administered via the control unit must be prescribed by a physician. The size, weight, cardiac status, blood volume status and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
Medical devices of class IIa.
Notified body: BSI NL (CE 2797).
Legal Manufacturer: Gambro Industries SAS, Meyzieu, France.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Prismaflex
TPE 1000 and 2000 set
MDD
Intended use: The Prismaflex TPE 1000 / TPE 2000 set is indicated for use only with the Prismaflex control unit or with PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE 1000 / TPE 2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components is indicated.
Medical devices of class IIb.
Notified body: TUV SUD (CE0123).
Legal manufacturer: Gambro Industries, Meyzieu, France.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
PrisMax System Version 3.x.
MDR
Intended purpose: Intended to perform the following specific extracorporeal therapies: Continuous Renal Replacement Therapy, Therapeutic Plasma Exchange, Hemoperfusion and Extracorporeal CO2 Removal.
Medical devices of class IIb.
Notified body: TUV SUD (CE 0123).
Legal Manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the manual for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Prismaflex
MDD
Intended purpose: The Prismaflex control unit is intended for: Continuous Renal Replacement Therapy for patients with acute renal failure and/or fluid overload, Therapeutic Plasma Exchange Therapy for patients with diseases where removal of plasma components is indicated, Hemoperfusion for patients with conditions where immediate removal of substances by adsorption is indicated, Hemopurification for patients with conditions where extracorporeal elimination of carbon dioxide is indicated.
Medical devices of class IIb.
Notified body: BSI, NL (CE 2797).
Legal Manufacturer: Gambro Lundia AB, Lund, Sweden.
Refer to the manual for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
PrismaLung+
MDD
Intended purpose: PrismaLung+ as single use device is intended to partially remove CO2 from the patient’s venous blood stream by diffusion through a membrane. It is intended to reduce increased level of CO2 in patient blood or to prevent an increase in CO2 blood levels and respiratory acidosis due to hypercapnia.
Medical devices of class IIa.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, 8010 Zurich, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
oXiris set
MDR
Intended purpose: The oXiris set is a single use device that provides blood purification via diffusion, convection and adsorption through a semipermeable membrane. The oXiris set is for use only in conjunction with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). All treatments administered with the oXiris set must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
Medical devices of class III.
Notified body: TÜV SÜD (CE 0123)
Legal manufacturer: Baxter Healthcare SA, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
MDR
Intended purpose: The oXiris set is a single use device that provides blood purification via diffusion, convection and adsorption through a semipermeable membrane. The oXiris set is for use only in conjunction with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). All treatments administered with the oXiris set must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
Medical devices of class III.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
TherMax Blood Warmer Unit
MDR
Intended purpose: The TherMax Blood Warmer Unit is intended for use in combination with TherMax Blood Warmer Disposable and the PrisMax control unit using Prismaflex blood tubing sets for the warming of blood during extracorporeal blood circulation.
Medical devices of class IIb.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
TherMax Blood Warmer Disposable
MDD
Intended purpose: The TherMax Blood Warmer Accessory includes the Blood Warmer Unit and Blood Warmer Disposable. It is intended for use in combination with the PrisMax control unit using Prismaflex blood tubing sets for the warming of blood during extracorporeal blood circulation.
Medical devices of class IIa.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, 8010 Zurich, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
MDR
Intended purpose: The TherMax Blood Warmer Disposable is intended for use in combination with Blood Warmer Unit and the PrisMax control unit using Prismaflex blood tubing sets for the warming of blood during extracorporeal blood circulation.
Medical devices of class IIa.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Effluent Bag 5L
MDD
Intended purpose: The device is an accessory to the Prismaflex and PrisMax control units for hemodialysis and is used to capture effluent fluids produced during Continuous Renal Replacement Therapy (CRRT).
Medical devices of class I.
Legal manufacturer: Gambro UF Solutions, Inc., MN, USA.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Auto Effluent Accessory
MDD
Intended purpose: The Auto Effluent Accessory is intended for use only with the PrisMax control unit in providing automatic effluent draining.
Medical devices of class I.
Legal manufacturer: Gambro UF Solutions, Inc., MN, USA.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Auto Effluent Extension
MDD
Intended purpose: Auto Effluent Extension is intended to extend the length of the drain line of the Auto Effluent Accessory in cases where a drain is longer than twenty feet (6 meters) away.
Medical devices of class I.
Legal manufacturer: Gambro UF Solutions, Inc., MN, USA.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
GamCath Catheter Dialysis Kits
MDR
Intended purpose: GamCath Dialysis Catheter Kits are used to obtain vascular access to perform extracorporeal blood purification. They consist of its main component, a GamCath Dialysis Catheter, and various accessories, that are used to insert the Catheter into the subclavian, jugular, or femoral vein.
Medical devices of class III.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
MDR
Intended purpose: GamCath Dialysis Catheter Kits are used to obtain vascular access to perform extracorporeal blood purification. They consist of its main component, a GamCath Dialysis Catheter, and various accessories, that are used to insert the Catheter into the subclavian, jugular, or femoral vein.
Medical devices of class III.
Notified body: TÜV SÜD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
GamCath HighFlow Dolphin Protect Catheter Kits
MDR
Intended purpose: GamCath HighFlow Dolphin Protect Catheter Kits are used to obtain vascular access to perform extracorporeal blood purification. They consist of its main component, a GamCath HighFlow Dolphin Protect Catheter, and various accessories that are used to insert the Catheter into the subclavian, jugular, or femoral vein.
Medical devices of class III.
Notified body: TUV SUD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
MDR
Intended purpose: GamCath HighFlow Dolphin Protect Catheter Kits are used to obtain vascular access to perform extracorporeal blood purification. They consist of its main component, a GamCath HighFlow Dolphin Protect Catheter, and various accessories that are used to insert the Catheter into the subclavian, jugular, or femoral vein.
Medical devices of class III.
Notified body: TUV SUD (CE 0123).
Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland / Baxter Healthcare SA, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Carefully read the Instructions for Use.
Date of preparation: January 2026.
Calcium Line for Prismaflex - CA250
MDR
Intended purpose: The Calcium Line for Prismaflex is a medical device to be used only with the PrisMax Control Unit (in countries where PrisMax is cleared or registered) or with the Prismaflex Control Unit software version 5.0 or later for performing the ‟Citrate-calcium via internal syringe pump” anticoagulation method. Carefully read the Control Unit Operator’s Manual and on-line screen instructions. All treatments administered via the Calcium Line for Prismaflex must be prescribed by a physician.
Medical devices of class IIa.
Notified body: DNV MEDCERT GmbH (0482).
Legal manufacturer: Medizintechnik GmbH, Kleiner Moorweg 4, 25436 Tornesch, Germany.
Refer to packaging leaflet for safe and proper use.
Date of preparation: January 2026.
MARS Treatment Kit
MDR
Intended purpose: The MARS Treatment kit as a single-use device is one component for the MARS System (Molecular Adsorbents Recirculating System), that is intended to provide a detoxification procedure for the treatment of liver failure. The detoxification is achieved by dialyzing the patient’s blood against an albumin containing solution.
Medical devices of class IIb.
Notified body: TUV SUD (CE 0123).
Legal manufacturer: Baxter Healthcare SA, Glattpark, Switzerland.
Refer to the package leaflet for safe and proper use.
Date of preparation: January 2026.
MARS Monitor 1TC
MDD
Intended purpose: The MARS method is used to remove protein-bound and/or water-soluble toxins from the blood, primarily in patients with acute or chronic liver failure, frequently accompanied by endogenous intoxication, jaundice (icterus) or comatose conditions.
Medical devices of class IIb.
Notified body: BSI NL (CE 2797).
Legal manufacturer: Gambro Lundia AB, Lund, Sweden.
Refer to the package leaflet for safe and proper use.
Date of preparation: January 2026.