Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1713747

FEI Number

1713747

Entity Name

Fresenius USA Manufacturing, Inc.

City/State/Country

Ogden, UT, US

Establishment Address

475 WEST 13TH ST., Ogden, UT 84404, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fresenius Medical Care Renal Therapies Group, LLC (Owner Number: 9030510)

Owner / Operator Contact Address

920 WINTER STREET, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192707

PMA Number

N/A

All Registered Proprietary Names

Hemoflow F4 Dialyzer Hemoflow F3 Dialyzer Optiflux F160NR, F180NR, F200NR, F250NR Dialyzers Optiflux F180NR Dialyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FJI	Dialyzer, Capillary, Hollow Fiber	Gastroenterology, Urology	Class 2	876.5820	2019-08-27
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-05-09
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2020-09-22

Official Correspondent

Rachel Lloyd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fresenius Medical Care Renal Therapies Group, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023981687	Erika of Texas	Pharr, TX, US
3012364195	Fresenius Medical Care de Mexico	Zapopan Jalisco, MX
3031565407	Erika de Reynosa, S.A. de C.V.	CD, Reynosa Tamaulipas, MX
3005578748	Haemotec, a division of Fresenius Medical Care Canada Inc.	VAUDREUIL-DORION Quebec, CA
3013546115	Fresenius USA Manufacturing, Inc.	Knoxville, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864831	Cobe Laboratories, Inc.	COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS	1987-03-27
K772290	Redy Laboratories	DIALYZER, CAPILATORY, HOLLOW FIBER	1978-03-15
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2026	Fresenius Medical Care Holdings, Inc.	2	Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag

Similar Registrations

Registration Number	Establishment Name	Location
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1932668	MOLDED PRODUCTS INC.	HARLAN, IA, US
3038195011	Vantive US Healthcare LLC	Deerfield, IL, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
2028411	REPROCESSING PRODUCTS CORPORATION (RPC)	TUCSON, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1713747. Last updated year: 2026. Please use registration number 1713747 when referencing this establishment in official correspondence.