Fresenius USA Manufacturing, Inc.

Matched from indexed company URL: FRESENIUS USA

FDA Registration(s)#

Registration, FEI, Name table
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
2937457	2937457	FRESENIUS USA, INC.	1	N	2020-04-25	4040 Nelson Ave Concord CA US 94520
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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00840861100897	2008® Series Hemodialysis Machines - 2008T HEMODIALYSIS SYS., with CDX	+1(800)227-2572	xxx@xxx.xxx
00840861100903	2008® Series Hemodialysis Machines - 2008T HEMODIALYSIS SYSTEM WITHOUT CDX	+1(800)227-2572	xxx@xxx.xxx
00840861100934	2008® Series Hemodialysis Machines - 2008T HD SYSTEM WITH CDX, CANADA	+1(800)227-2572	xxx@xxx.xxx
00840861100941	2008® Series Hemodialysis Machines - 2008K@HOME HEMODIALYSIS SYSTEM	+1(800)227-2572	xxx@xxx.xxx
00840861100965	2008® Series Hemodialysis Machines - 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG	+1(800)227-2572	xxx@xxx.xxx
00840861102198	VersiPD - VersiPD Cycler	1-800-323-5188	xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
162236	1532449650	K994267	FRESENIUS 2008K	KDI	2000-03-16
17132	1527473225	K981043	DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL	KPO	1998-05-26
17133	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
162236	1112799723	K955762	PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM	KPF	1996-07-31
162236	2021603213	K935958	CRIT-LINE BLOOD CHAMBER WITH E-BEAM	KOC	1995-01-19
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
17132	1625657054	K212620	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	KPO	2022-05-12
17133	1625657054	K212620	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	KPO	2022-05-12
17131	1458191945	K192707	Optiflux F180NR Dialyzer	KDI	2020-09-21
17132	1681571498	K192209	Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate	KPO	2020-05-08
17133	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
162236	1831260214	K181108	Fresenius Liberty Select Cycler	FKX	2018-05-24
162236	1187328696	K173972	2008T BlueStar Hemodialysis Machine	KDI	2018-05-10
162236	1071355928	K171652	Fresenius Liberty Select Cycler	FKX	2017-09-15
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
162236	1858750875	K153449	2008K2 Hemodialysis Machine	KDI	2016-04-26
162236	1368862327	K150708	2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine	KDI	2015-12-10
162236	1411997792	K141997	CRIT-LINE IV SYSTEM	KOC	2015-04-01
162236	1832003599	K141145	LIBERTY PDX CYCLER	FKX	2014-07-30
162236	1068960956	K133299	ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY	KDI	2014-07-07
162236	1970426534	K131611	FRESENIUS DRY ACID DISSOLUTION UNITS	KPO	2013-08-29
162236	1781972934	K124035	2008K@HOME HEMODIALYSIS MACHINE	ONW	2013-07-03
162236	1841707119	K123630	FRESENIUS LIBERTY CYCLER	FKX	2013-09-09
162236	1286801815	K121599	CRIT-LINE CLIP (CLIC)	KOC	2012-11-09
162236	1055599414	K121421	FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)	ONW	2013-01-17
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
162236	1683716697	K070049	FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR	ONW	2011-02-03
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
162236	1898084617	K011741	CRIT-LINE MONITOR III TQA (CLM TQA)	FIL	2002-07-23
162236	1461704573	K002892	FRSENIUS PD IQCARD CYCLER	FKX	2001-04-05
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KPO	20	2026-01-29
KDI	10	2025-05-30
FKX	5	2018-05-24
KOC	3	2015-04-01
ONW	3	2013-07-03
FJI	2	2019-08-23
FIL	1	2002-07-23
KPF	1	1996-07-31

PMN#

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
1999-08-04
FRESENIUS USA, INC.
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
1998-09-15
FRESENIUS USA, INC.
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
1998-05-14
FRESENIUS USA, INC.
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
1997-11-03
FRESENIUS USA, INC.
2008H ON LINE CLEARANCE MONITOR
1997-07-03
FRESENIUS USA, INC.
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
1996-07-31
FRESENIUS USA, INC.
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
1996-07-31
FRESENIUS USA, INC.
Automated Blood Cell Separator -Filtration
1996-07-22
Fresenius USA/Seratronics Inc.
FRESENIUS BLOOD TEMPERATURE MONITOR
1996-07-03
FRESENIUS USA, INC.
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
1996-06-13
FRESENIUS USA, INC.
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
1995-11-29
FRESENIUS USA, INC.
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
1995-11-29
FRESENIUS USA, INC.
FRESENIUS DIALYSATE ACID CONCENTRATE
1994-10-17
FRESENIUS USA, INC.
FRESENIUS HEMOFLOW, VARIOUS MODELS
1994-08-23
FRESENIUS USA, INC.
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
1994-04-20
FRESENIUS USA, INC.
GRANULYTE DIALYSATE CONCENTRATE
1994-03-30
FRESENIUS USA, INC.
FRESENIUS POLYSULFONE DIALYZERS
1993-12-02
FRESENIUS USA, INC.
FRESENIUS PD+ EXCHANGE DEVICE
1993-07-01
FRESENIUS USA, INC.
FRESENIUS VARIABLE FILL MONITOR
1993-02-25
FRESENIUS USA, INC.
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
1991-07-24
FRESENIUS USA, INC.
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
1991-07-17
FRESENIUS USA, INC.
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
1991-01-11
FRESENIUS USA, INC.
FRESENIUS AS 104 CELL SEPARATOR
1990-11-02
FRESENIUS USA, INC.
RESUBMITTED MULTIORGAN PERFUSION CANNULA
1990-09-27
FRESENIUS USA, INC.
IONOMETER EF-HK AND ACCESSORIES
1990-07-31
FRESENIUS USA, INC.
IONOMETER EH-F AND ACCESSORIES
1990-07-19
FRESENIUS USA, INC.
IONOMETER EH
1990-06-28
FRESENIUS USA, INC.
IONOMETER EH-HK AND ACCESSORIES
1990-06-18
FRESENIUS USA, INC.
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
1990-05-02
FRESENIUS USA, INC.
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
1989-12-27
FRESENIUS USA, INC.
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
1989-05-11
FRESENIUS USA, INC.
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
1989-05-11
FRESENIUS USA, INC.
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
1989-04-25
FRESENIUS USA, INC.
EURO-COLLINS SOLUTION SETS
1989-01-26
FRESENIUS USA, INC.
FRESENIUS F8 DIALYZER
1988-09-13
FRESENIUS USA, INC.
Blood And Plasma Warming Devices
1988-08-25
Fresenius USA/Seratronics Inc.
MODEL BPS08 BLOOD PRESSURE MODULE
1988-07-28
FRESENIUS USA, INC.
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
1988-04-15
FRESENIUS USA, INC.
ENTERNAL FEEDING PUMP BATTERY OPER.
1985-04-30
FRESENIUS USA, INC.
FREKATHETER VENOUS CATHETERISATION SYS
1984-04-25
FRESENIUS USA, INC.

GUDID#

VersiPD - VersiPD Cart
Fresenius Usa, Inc.
2023-08-01
2008® Series Hemodialysis Machines - 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Fresenius Usa, Inc.
2015-09-24
VersiPD - VersiPD Dialysate Solution Bag Case
Fresenius Usa, Inc.
2023-02-14
VersiPD - VersiPD Cycler
Fresenius Usa, Inc.
2023-02-14
2008® Series Hemodialysis Machines - 2008K@HOME HEMODIALYSIS SYSTEM
Fresenius Usa, Inc.
2015-09-24
2008® Series Hemodialysis Machines - 2008T HD SYSTEM WITH CDX, CANADA
Fresenius Usa, Inc.
2016-06-06
2008® Series Hemodialysis Machines - 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
Fresenius Usa, Inc.
2015-09-30
2008® Series Hemodialysis Machines - 2008T HEMODIALYSIS SYS., with CDX
Fresenius Usa, Inc.
2015-09-30
Fresenius - JUG WAND, WHITE
Fresenius Usa, Inc.
2015-10-02
Fresenius - JUG WAND, RED
Fresenius Usa, Inc.
2015-10-02
Fresenius - JUG WAND, BLUE
Fresenius Usa, Inc.
2015-10-02
Fresenius - BLUE BICARB CONCENTRATE WAND (US)
Fresenius Usa, Inc.
2015-10-02
Crit-Line® - Blood Chamber II
Fresenius Usa, Inc.
2016-10-04
WetAlert™ wireless wetness detector - 190507
Fresenius Usa, Inc.
2015-09-24
Crit-Line® - Blood Chamber II
Fresenius Usa, Inc.
2016-10-04
Dry Acid Dissolution Unit - 99 Gallon
Fresenius Usa, Inc.
2015-10-02
Dry Acid Dissolution Unit - 132 Gallon
Fresenius Usa, Inc.
2015-10-02
Liberty® PDx - Liberty® PDx CYCLER
Fresenius Usa, Inc.
2015-10-02
Liberty® - Liberty® Cycler
Fresenius Usa, Inc.
2015-10-02
2008® Series Hemodialysis Machines - 2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
Fresenius Usa, Inc.
2015-09-24
2008® Series Hemodialysis Machines - 2008T GEN 2 BIBAG WITHOUT CDX
Fresenius Usa, Inc.
2015-09-30
2008® Series Hemodialysis Machines - 2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG
Fresenius Usa, Inc.
2015-09-30
2008® Series Hemodialysis Machines - 2008K2 HEMO SYSTEM, OPTIONAL 5th MODULE
Fresenius Usa, Inc.
2015-09-30
2008® Series Hemodialysis Machines - 2008K2 MACHINE, SHORT CAB, OLC/DP, HP
Fresenius Usa, Inc.
2015-09-30
2008® Series Hemodialysis Machines - 2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS
Fresenius Usa, Inc.
2015-09-30
Crit-Line® - Viewing window for CLiC technology
Fresenius Usa, Inc.
2015-10-19
Crit-Line® - Viewing window for CLiC technology
Fresenius Usa, Inc.
2015-10-19