Question 1

What does Fresenius Usa, Inc. manufacture?

Accepted Answer

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.

Question 2

Where is Fresenius Usa, Inc. based?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Granulyte Dialysate Concentrate	K922005	FDA 510(k)	Class II	Active
Fresenius As 104 Cell Separator	K895435	FDA 510(k)	U	Active
Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/Tubing Set F3000ts	K992275	FDA 510(k)	Class II	Active
Ionometer Eh-F And Accessories	K901040	FDA 510(k)	Class II	Active
Fresenius 2008 Touch Panel Control Dialysis System	K890824	FDA 510(k)	Class II	Active
Frekatheter Venous Catheterisation Sys	K841718	FDA 510(k)	N/A	Active
Ionometer Eh-Hk And Accessories	K901041	FDA 510(k)	Class II	Active
Model Bps08 Blood Pressure Module	K881155	FDA 510(k)	Class II	Active
Fresenius Polysulfone Dialyzers	K921134	FDA 510(k)	Class II	Active
Ionometer Eh	K901039	FDA 510(k)	Class II	Active
Enternal Feeding Pump Battery Oper.	K841104	FDA 510(k)	N/A	Active
C.a.t.s Continuous Autotransfusion System Model 900500 1, At1 Autotransfusion Set Model 900 510 1, Psq Set (dd) Model 61	K973378	FDA 510(k)	Class II	Active
Fresenius F Series Hemoconcentrators F400, F500, F700, F800, F400ts, F500ts, F700s, F800ts	K974584	FDA 510(k)	Class II	Active

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