Fresenius USA Manufacturing, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1651896 | 3003310249 | Fresenius USA Manufacturing, Inc. | 1 | N | 2026-01-01 | 5201 Regent Blvd IRVING TX US 75063 |
| 1713747 | 1713747 | Fresenius USA Manufacturing, Inc. | 1 | N | 2026-01-01 | 475 WEST 13TH ST. Ogden UT US 84404 |
| 3005162618 | 1527681 | Fresenius USA Manufacturing, Inc. | 1 | N | 2026-01-01 | 750 North Lallendorf Rd OREGON OH US 43616 |
| 3009242923 | 3009242923 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2026-01-01 | 371 S. Royal Lane DFW Airport TX US 75261 |
| 3010039371 | 3010039371 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2026-01-01 | 555 Blue Heron Dr SUITE 100 Oregon OH US 43616 |
| 3012417381 | 3012417381 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2026-01-01 | 2865 DAVE LYLE BLVD Rock Hill SC US 29730 |
| 3012786295 | 3012786295 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2026-01-01 | 69 Tetz Rd, Suite 2A Chester NY US 10918 |
| 3013546115 | 3013546115 | Fresenius USA Manufacturing, Inc. | 1 | N | 2026-01-01 | 5105 South National Drive Knoxville TN US 37914 |
| 3017125096 | 3017125096 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2026-01-01 | 5304 East Governor John Sevier Highway Knoxville TN US 37914 |
| 3012357647 | 3012357647 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 885 CORPORATE WOODS DRIVE Alabaster AL US 35007 |
| 3012514391 | 3012514391 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 3415 BRONZE COURT Shasta Lake CA US 96019 |
| 3012526302 | 3012526302 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 18925 NAVAJO ROAD Apple Valley CA US 92307 |
| 3012926763 | 3012926763 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 10550 SOUTHPORT DRIVE Orlando FL US 32824 |
| 3012995006 | 3012995006 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 600 Sharkey Dr Maumelle AR US 72113 |
| 3014104886 | 3014104886 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 15 RITTER WAY Lebanon PA US 17042 |
| 3014128998 | 3014128998 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 375 NORTH DEPOT DRIVE Ogden UT US 84404 |
| 3014129558 | 3014129558 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 549 SAGE SAND ROAD Los Lunas NM US 87031 |
| 3014146136 | 3014146136 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 360 Cedar Street Suite 2 Marlboro MA US 01752 |
| 3014158893 | 3014158893 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 5300 95TH AVENUE Kenosha WI US 53144 |
| 3014844728 | 3014844728 | Fresenius USA Manufacturing, Inc. | 1 | Y | 2020-04-25 | 10904 Painter Ave, Unit C Santa Fe Spgs CA US 90670 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 17133 | 1527473225 | K981043 | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL | KPO | 1998-05-26 |
| 17132 | 1527473225 | K981043 | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL | KPO | 1998-05-26 |
| 17132 | 1300616115 | K980659 | DRYALYSATE CONCENTRATE | KPO | 1998-06-11 |
| 17131 | 1591516136 | K870725 | FRESENIUS HEMOFLOW F6 AND F8 | FJI | 1987-05-01 |
| 17133 | 1673334042 | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | KPO | 2026-01-29 |
| 17132 | 1673334042 | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | KPO | 2026-01-29 |
| 17133 | 1715745078 | K243505 | 5008X Hemodialysis System | KDI | 2025-05-30 |
| 17133 | 1625657054 | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | 2022-05-12 |
| 17132 | 1625657054 | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | 2022-05-12 |
| 17131 | 1458191945 | K192707 | Optiflux F180NR Dialyzer | KDI | 2020-09-21 |
| 17133 | 1681571498 | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | KPO | 2020-05-08 |
| 17132 | 1681571498 | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | KPO | 2020-05-08 |
| 17132 | 1107381683 | K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | 2020-04-24 |
| 17133 | 1082713033 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | KPO | 2020-02-24 |
| 17132 | 1082713033 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | KPO | 2020-02-24 |
| 17131 | 1473419817 | K190459 | Hemoflow F3 and F4 Dialyzers | FJI | 2019-08-23 |
| 234161 | 1880094701 | K162716 | bibag | KPO | 2017-05-18 |
| 17131 | 1880094701 | K162716 | bibag | KPO | 2017-05-18 |
| 17131 | 1022678672 | K162488 | Optiflux dialyzer | KDI | 2017-04-06 |
| 17133 | 1629522469 | K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES | KPO | 2007-03-29 |
| 17132 | 1629522469 | K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES | KPO | 2007-03-29 |
| 17131 | 1221974634 | K043244 | FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR | KDI | 2004-12-20 |
| 17132 | 2064210324 | K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES | KPO | 2003-05-20 |
| 17133 | 2064210324 | K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES | KPO | 2003-05-20 |
| 17131 | 1455131653 | K002277 | FRESENIUS OPTIFLUX 200NR | KDI | 2000-08-25 |
| 17133 | 1251242227 | K000792 | CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX | KPO | 2000-06-08 |