Fresenius Usa Manufacturing Inc

FDA Filings

This page includes the latest FDA filings for Fresenius Usa Manufacturing Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1713747
• FEI Number: 1713747
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 475 WEST 13TH ST. ; Ogden, UT 84404 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3014129558
• FEI Number: 3014129558
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 549 SAGE SAND ROAD ; Los Lunas, NM 87031 US

• Registration Number: 3010039371
• FEI Number: 3010039371
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 555 Blue Heron Dr SUITE 100; Oregon, OH 43616 US

• Registration Number: 3014146136
• FEI Number: 3014146136
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 360 Cedar Street Suite 2; Marlboro, MA 01752 US

• Registration Number: 3012995006
• FEI Number: 3012995006
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 600 Sharkey Dr ; Maumelle, AR 72113 US

• Registration Number: 3012357647
• FEI Number: 3012357647
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 885 CORPORATE WOODS DRIVE ; Alabaster, AL 35007 US

• Registration Number: 3012526302
• FEI Number: 3012526302
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 18925 NAVAJO ROAD ; Apple Valley, CA 92307 US

• Registration Number: 1651896
• FEI Number: 3003310249
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5201 Regent Blvd ; IRVING, TX 75063 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3005162618
• FEI Number: 1527681
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 750 North Lallendorf Rd ; OREGON, OH 43616 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3014104886
• FEI Number: 3014104886
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 15 RITTER WAY ; Lebanon, PA 17042 US

• Registration Number: 3014844728
• FEI Number: 3014844728
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 10904 Painter Ave, Unit C ; Santa Fe Spgs, CA 90670 US

• Registration Number: 3013546115
• FEI Number: 3013546115
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5105 South National Drive ; Knoxville, TN 37914 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3012514391
• FEI Number: 3012514391
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3415 BRONZE COURT ; Shasta Lake, CA 96019 US

• Registration Number: 3009242923
• FEI Number: 3009242923
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 371 S. Royal Lane ; DFW Airport, TX 75261 US

• Registration Number: 3014128998
• FEI Number: 3014128998
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 375 NORTH DEPOT DRIVE ; Ogden, UT 84404 US

• Registration Number: 3012417381
• FEI Number: 3012417381
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2865 DAVE LYLE BLVD ; Rock Hill, SC 29730 US

• Registration Number: 3014158893
• FEI Number: 3014158893
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5300 95TH AVENUE ; Kenosha, WI 53144 US

• Registration Number: 3012786295
• FEI Number: 3012786295
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 69 Tetz Rd, Suite 2A ; Chester, NY 10918 US

• Registration Number: 3012926763
• FEI Number: 3012926763
• Name: Fresenius USA Manufacturing, Inc.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 10550 SOUTHPORT DRIVE ; Orlando, FL 32824 US

FDA Filings

Device Company	Device	Date
PMN K191474 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	NaturaLyte Dry Bicarbonate Concentrate	2020-03-02
PMN K191474 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	NaturaLyte Dry Bicarbonate Concentrate	2020-03-02
PMN K190459 | FJI Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Hemoflow F4 Dialyzer	2019-08-27
PMN K190459 | FJI Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Hemoflow F3 Dialyzer	2019-08-27
PMN K162716 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	bibag 08-4080-BB (900g)	2017-06-15
PMN K162716 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	bibag 08-4078-BB (650g)	2017-06-15
PMN K162488 | KDI Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Optiflux F160NR, F180NR, F200NR, F250NR Dialyzers	2017-05-09
PMN K980659 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	DRYalysate Concentrate	2012-03-02
PMN K000792 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Citrasate Dialysate Acid Concentrate Liquid	2012-03-02
PMN K870725 | FJI Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Hemoflow F8 Dialyzer	2008-01-08
PMN K870725 | FJI Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Hemoflow F6 Dialyzer	2008-01-08
PMN K070177 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Naturalyte Liquid or Powder	2008-01-08
PMN K070177 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	Naturalyte Liquid or Powder	2008-01-08
PMN K030497 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	GranuFlo Dry Acid Concentrate	2007-11-28
PMN K030497 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	GranuFlo Dry Acid Concentrate	2007-11-28
PMN K981043 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	NaturaLyte Liquid Acid Concentrate	2007-05-22
PMN K981043 | KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	NaturaLyte Liquid Acid Concentrate	2007-05-22

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092663213	Anvers,Belgium -> Houston, Texas	= UPON 25 PALLETS REF: 6002 5246 DISC SYSTEM CONNECTOR SRAY-SAFEE LUER-LOCK ADAPTER HS-COD E: 391740, 901839,	735 PKG
2020092663213	Anvers,Belgium -> Houston, Texas	= UPON 25 PALLETS REF: 6002 5245 BIOFINE FILM HS- CODE: 392010	735 PKG
2020092213827	Stadersand,Federal Republic of Germany -> Oakland, California	MEDICAL AND PHARMACEUTICAL PRODUCTS	29 PKG
2020092213827	Stadersand,Federal Republic of Germany -> Oakland, California	MEDICAL AND PHARMACEUTICAL PRODUCTS	29 PKG
2020092135766	La Spezia,Italy -> Houston, Texas	PATIENT CONNECTOR PC ASSEMBLED HC 3926 9099 9 00	11 PKG
2020092117240	Stadersand,Federal Republic of Germany -> Oakland, California	MEDICAL AND PHARMACEUTICAL PRODUCTS	29 PKG
2020092117240	Stadersand,Federal Republic of Germany -> Oakland, California	MEDICAL AND PHARMACEUTICAL PRODUCTS	29 PKG
2020082947721	Shanghai ,China (Mainland) -> Los Angeles, California	SOL-CARE 1ML TB SAFETY SYRINGE W FIXED NEEDLE 22G+1 1 2	125 CTN
2020082458796	Shanghai ,China (Mainland) -> Los Angeles, California	SOL-CARE 1ML TB SAFETY SYRINGE W FIXED NEEDLE 22G+1 1 2	125 CTN
2020081161917	Shanghai ,China (Mainland) -> Long Beach, California	SOL-M ISOLATION GOWN	1250 CTN
2020080424288	Shanghai ,China (Mainland) -> Long Beach, California	SOL-M ISOLATION GOWN	3750 CTN
2020080424288	Shanghai ,China (Mainland) -> Long Beach, California	SOL-M ISOLATION GOWN	3750 CTN
2020080424288	Shanghai ,China (Mainland) -> Long Beach, California	SOL-M ISOLATION GOWN	3750 CTN