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Gambro Renal Products, Inc.

Last updated May 30, 2026

Information

Country: US
Address: —
Website: baxter.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)933-0303
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 929768682

Catalogue (41)

Device	Model / Reference	Registries	Class	Status
Polyflux Revaclear Max	110634	FDA UDI	Class II	Unknown
Polyflux Revaclear	110633	FDA UDI	Class II	Unknown
Revaclear	400	FDA UDI	Class II	Active
Revaclear	300	FDA UDI	Class II	Active
Gambro Polyflux Hd-C4 Capillary Dialyzer/Filter For Single Use	K060195	FDA 510(k)	Class II	Active
Dry Ac Acid Concentrate Mix For Bicarbonate Hemodialysis	K011368	FDA 510(k)	Class II	Active
Polyflux 14l, 17l, 21l Hemodialyzer/Filter Labeled For Single Use	K040255	FDA 510(k)	Class II	Active
Prismaflex System 7.10	K131516	FDA 510(k)	Class II	Active
Prismaflex M150 Set	K080519	FDA 510(k)	Class II	Active
Molecular Adsorbent Recirculating(mars)	K113313	FDA 510(k)	Class II	Active
Modification To: Dryac Acid Concentrate Mix For Bicarbonate Hemodialysis	K052253	FDA 510(k)	Class II	Active
Gambro Prismaflex And Gambro Prismaflex M60 & M100 Sets	K041005	FDA 510(k)	Class II	Active
Phoenix Hemodialysis Delivery System, Gambro Cartridge For Hemodialysis Blood Tubing Set	K001156	FDA 510(k)	Class II	Active
Gamcath High Flow Dolphin Ms-Gdhc-1315 A; And Ms-Gdhc-1315j A, Gamcath High Flow Dolphin Ms-Gdhc-1320 A; And Ms-Gdhc-132	K100451	FDA 510(k)	Class II	Active
Prismaflex	K110823	FDA 510(k)	Class II	Active
Prisma System	K010805	FDA 510(k)	Class II	Active
Phoenix Hemodialysis Delivery System	K103832	FDA 510(k)	Class II	Active
Prisma M10 Pre Set	K063183	FDA 510(k)	Class II	Active
Gambro Quickset Bloodlines	K063290	FDA 510(k)	Class II	Active
Revaclear 300 Dialyzer, Revaclear 400 Dialyzer	K130039	FDA 510(k)	Class II	Active
Prismasate	K013448	FDA 510(k)	Class II	Active
Gambro Polyflux 24s, Gambro Polyflux 24r	K010667	FDA 510(k)	Class II	Active
Bicart	K013724	FDA 510(k)	Class II	Active
Prisma Hf 1000 Set, Prisma Hf 1000 Pre-Set	K011221	FDA 510(k)	Class II	Active
Diaclear Ultrafilter	K003957	FDA 510(k)	Class II	Active
Molecular Adsorbent Recirculating System (mars)	K033262	FDA 510(k)	Class II	Active
Gambro Polyflux 6 Lr, 8 Lr And 10 Lr	K023615	FDA 510(k)	Class II	Active
Mars Monitor Itc Us, Mars Treatment Kit Type 1116/1 - X-Mars Us, Prismaflex Control Unit	K133807	FDA 510(k)	Class II	Active
Gambro Prismaflex Hf1000 And Hf1400 Sets	K042938	FDA 510(k)	Class II	Active
Prismasate Dialysis Solutions For Continuius Renal Replacement Therapy	K120333	FDA 510(k)	Class II	Active
Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520	K100364	FDA 510(k)	Class II	Active
Gamcath High Flow Catheter, Ref: Gdhk 13xx A	K040301	FDA 510(k)	Class II	Active
Prismasate Dialysis Solutions For Continuous Renal Replacement Therapy	K072908	FDA 510(k)	Class II	Active
Gambro Polyflux 6l, Gambro Polyflux 8l, Gambro Polyflux 10l, Model 6l, 8l, 10l	K010985	FDA 510(k)	Class II	Active
Polyflux Family Hemodialyzer/Filter Labeled For Single And Multiple Use, Models 14l, 17l, 21l, 140h, 170h, 210h, 6lr, 8lr	K043342	FDA 510(k)	Class II	Active
Wro 300 Water Purification System For Hemodialysis	K042797	FDA 510(k)	Class II	Active
Prisma System R03.10a	K062090	FDA 510(k)	Class II	Active
Gambro Cartridge Blood Sets	K070414	FDA 510(k)	Class II	Active
Gambro Water Purification Unit, Models Wro 300 And Wro 300 H	K093608	FDA 510(k)	Class II	Active
Gambro Polyflux Hemodialyzer, Model 6h	K051520	FDA 510(k)	Class II	Active
Gambro Polyflux Hemodialyzer, Model: Hd-C4 Small	K072232	FDA 510(k)	Class II	Active

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 5, 2014	Z-0490-2015	—	terminated	Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
Nov 5, 2014	Z-0489-2015	—	terminated	Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
May 2, 2008	Z-1860-2008	—	terminated	Dialysis tubing sets may have occlusions restricting blood flow.
May 2, 2008	Z-1861-2008	—	terminated	Dialysis tubing sets may have occlusions restricting blood flow.
Sep 10, 2007	Z-1367-2008	—	terminated	Kinked tubing on hemodialysis device may cause hemolysis.
Jan 4, 2007	Z-0695-2007	—	terminated	Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
May 16, 2006	Z-0032-2007	—	terminated	A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
May 12, 2006	Z-0200-2007	—	terminated	Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
Oct 24, 2005	Z-0705-06	—	terminated	After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
Oct 24, 2005	Z-0706-06	—	terminated	After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
Aug 16, 2005	Z-1545-05	—	terminated	Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.
Nov 13, 2002	Z-0307-03	—	completed	Gambro's ClinicalKit 15G safety Kits contain the Nipro Safetouch Safety Fistula Needles currently being recalled by Nipro for leakage problems