Fresenius USA Manufacturing, Inc.

FDA Device Registration & Listing · IRVING, TX, US · Registration 1651896

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1651896
FEI Number
3003310249
Entity Name
Fresenius USA Manufacturing, Inc.
City/State/Country
IRVING, TX, US
Establishment Address
5201 Regent Blvd, IRVING, TX 75063, 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
N
Expiration Date (Year)
2026
510(k) Number
K212620
PMA Number
N/A

All Registered Proprietary Names

Granuflo Dry Acid Concentrate Citrasate Dry Acid Concentrate Citrasate Liquid Acid Concentrate NaturaLyte Liquid Acid Concentrate NaturaLyte Dry Bicarbonate Concentrate NaturaLyte Liquid Acid Concentrate Citrasate Liquid Acid Concentrate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-05-14
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-05-08
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-03-02
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2022-11-21

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

Similar Registrations

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9616277 S.M.A.D. L'ARBRESLE Rhone, FR
3027241826 RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. El Marques Queretaro, MX
1225714 Fresenius Medical Care Renal Therapies Group, LLC Waltham, MA, US
1528807 Nipro Renal Solutions USA, Corporation LEWISBERRY, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1651896. Last updated year: 2026. Please use registration number 1651896 when referencing this establishment in official correspondence.
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