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Fresenius Usa, Inc.

Last updated May 30, 2026

What Fresenius Usa, Inc. makes

Fresenius Usa, Inc. manufactures haemodialysis systems for institutional and home use, peritoneal dialysis systems, haemodialysis dialysate tubing, haemodialysis system fluid mixers, blood volume monitors, and blood leak detectors. Their specific products include the 2008® Series Hemodialysis Machines, WetAlert™ wireless wetness detector, VersiPD, and Dry Acid Dissolution Unit.

The company's devices are regulated under Class I, Class II, and U classifications and are listed in the FDA 510(k) and FDA UDI registries. Fresenius Usa, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Fresenius Usa, Inc. manufacture?

Where is Fresenius Usa, Inc. based?

Fresenius Usa, Inc. is based in the United States. The company operates within the US market, focusing on the development and distribution of medical devices related to dialysis treatments.

Which regulatory registries list Fresenius Usa, Inc.'s devices?

Fresenius Usa, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries. These registries track medical devices that have been notified to the FDA, ensuring proper regulation and identification in the market.

How are Fresenius Usa, Inc.'s devices classified?

Fresenius Usa, Inc.'s devices are regulated under Class I, Class II, and U classifications. These classifications determine the level of control required by the FDA, with Class I being low risk, Class II moderate risk, and U indicating unclassified devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-323-5188
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 076594100

Catalogue (63)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
2008® Series Hemodialysis Machines	190766	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190858	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190908	FDA UDI	Class II	Active
WetAlert™ wireless wetness detector	190507	FDA UDI	Class II	Active
VersiPD	130831	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190828	FDA UDI	Class II	Active
Dry Acid Dissolution Unit	160148	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190395	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190633	FDA UDI	Class II	Active
Fresenius	M52837	FDA UDI	Class II	Active
Crit-Line®	191058	FDA UDI	Class II	Active
Fresenius	M52836	FDA UDI	Class II	Active
VersiPD	130832	FDA UDI	Class II	Active
Fresenius	M52840	FDA UDI	Class II	Active
Crit-Line®	CL10041021	FDA UDI	Class II	Active
Liberty®	180111	FDA UDI	Class II	Active
Dry Acid Dissolution Unit	160147	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190713	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190630	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190610	FDA UDI	Class II	Active
Fresenius	M52838	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190895	FDA UDI	Class II	Active
VersiPD	130821	FDA UDI	Class II	Active
2008® Series Hemodialysis Machines	190904	FDA UDI	Class II	Active
Liberty® PDx	180237	FDA UDI	Class II	Active
Packpd Peritoneal Dialysis Urea Kinetic Modeling Software Program	K955762	FDA 510(k)	Class II	Active
Fresenius Biocarb Hemodialysis Grade Sodium Bicarb	K896111	FDA 510(k)	Class II	Active
Fresenius Hemoflow, F40m, F50m, F60m & F80m	K892262	FDA 510(k)	Class II	Active
Fresenius 3008/Fds-08 Dialysate Delivery System	K921456	FDA 510(k)	Class II	Active
Fresenius 2008 Bss Bedside Dialysis System	K890329	FDA 510(k)	Class II	Active
Fresenius Variable Fill Monitor	K921052	FDA 510(k)	Class II	Active
Fresenius Safe-Connect Capd Manual Assist Device	K912208	FDA 510(k)	Class II	Active
Capd Safelock Transfer Set W/Pre-Filled Connector	K904806	FDA 510(k)	Class II	Active
Ionometer Ef-Hk And Accessories	K901042	FDA 510(k)	Class II	Active
Fresenius Hemoflow, Various Models	K926005	FDA 510(k)	Class II	Active
Fresenius F8 Dialyzer	K883195	FDA 510(k)	Class II	Active
Resubmitted Multiorgan Perfusion Cannula	K902394	FDA 510(k)	Class II	Active
Pack H Hemodialysis Urea Kinetic Modeling Software Program	K955423	FDA 510(k)	Class II	Active
P1r Plasma Treatment Set For Use In Plasmapheresis With The Fresenius As104 Cell Separator	K961706	FDA 510(k)	U	Active
Dialysis Machine With Dialysate Ultrafilter	K944767	FDA 510(k)	Class II	Active
Biopure Dialysate Concentrate Mix Syst/Concentrate	K930181	FDA 510(k)	Class II	Active
Fresenius Dialysate Acid Concentrate	K922088	FDA 510(k)	Class II	Active
Granulyte Powder Dialysate Concentrate And Mixing	K911459	FDA 510(k)	Class II	Active
Fresenius Polysulfone Hemodialyzers, Both Low And High Flux	K970700	FDA 510(k)	Class II	Active
Glandosane (salivart) Synthetic Saliva	K874106	FDA 510(k)	U	Active
Enteral Pump Set With Entera (tm)-Flo Spike	K895366	FDA 510(k)	Class II	Active
Euro-Collins Solution Sets	K884609	FDA 510(k)	Class II	Active
Fresenius Pd+ Exchange Device	K915634	FDA 510(k)	Class I	Active
Fresenius Blood Temperature Monitor	K941460	FDA 510(k)	Class II	Active
2008h On Line Clearance Monitor	K961465	FDA 510(k)	Class II	Active

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