Fresenius Medical Care North America

FDA Filings

This page includes the latest FDA filings for Fresenius Medical Care North America. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Fresenius Medical Care North America holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)

Registration Number	8030665
FEI Number	3002807744
Name	Denise Oppermann
Owner & Operator	Fresenius Medical Care North America
Contact Address	920 WINTER STREET -- Waltham MA 02451 US
Official Correspondent	DENISE OPPERMANN x-781-6994479-x
US Agent	Denise Oppermann Fresenius Medical Care North America 781 6994479 781 6999635 denise.m.oppermann@fmc-na.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	920 Winter St. Waltham, MA 02451 US
Establishment Type	Manufacture Medical Device

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	3008730267
FEI Number	3008730267
Name	Erika of Texas
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	1100 E. Military Hwy Suite C Pharr, TX 78577 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	3016690564
FEI Number	3016690564
Name	Erika of Texas
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	5700 South International Parkway Suite A2 McAllen, TX 78503 US

Registration Number	1225714
FEI Number	3001451489
Name	FRESENIUS MEDICAL CARE NORTH AMERICA
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	920 WINTER STREET Waltham, MA 02451 US
Establishment Type	Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198

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	3015335038
FEI Number	3015335038
Name	ERIKA DE REYNOSA, S.A. DE C.V.
Owner & Operator	Fresenius Medical Care North America
Contact Address	920 WINTER STREET -- Waltham MA 02451 US
Official Correspondent	DENISE OPPERMANN x-781-6994479-x
US Agent	Denise Oppermann Fresenius Medical Care North America 781 6994479 781 6999635 denise.m.oppermann@fmc-na.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	MIKE ALLEN 1011 PARQUE INDUSTRIAL REYNOSA CD, REYNOSA Tamaulipas, 88780 MX
Establishment Type	Manufacture Medical Device

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	2937457
FEI Number	2937457
Name	FRESENIUS USA, 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	4040 Nelson Ave Concord, CA 94520 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
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2024-04-10
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2024-03-29
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2024-01-13
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2024-01-12
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-10-20
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-10-20
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-10-20
Sodium Chloride Fresenius Medical Care North America	Prescription Medication	2023-10-19
Sodium Chloride Fresenius Medical Care de Mexico, S.A. de C.V.	Prescription Medication	2023-10-19
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2023-10-19
Velphoro Fresenius Medical Care North America, Vifor Fresenius Medical Care Renal Pharma France	Prescription Medication	2023-10-19
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2023-10-17
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2023-09-30
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-09-06
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-09-06
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-09-06
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-08-18
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-08-18
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2023-08-05
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-07-06
Sodium Chloride Fresenius Medical Care North America	Prescription Medication	2023-05-20
Sodium Chloride Fresenius Medical Care de Mexico, S.A. de C.V.	Prescription Medication	2023-05-20
LACTATED RINGERS Becton Dickinson and Company, Fresenius Kabi Norge As, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America	Prescription Medication	2023-04-29
LACTATED RINGERS Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2023-04-29
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2023-04-20
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-03-31
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-03-31
DELFLEX Fresenius Medical Care North America	Prescription Medication	2023-03-18
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2023-03-08
Calcium Acetate Fresenius Medical Care North America	Prescription Medication	2023-02-02
DELFLEX Fresenius Medical Care North America	Prescription Medication	2022-11-10
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2022-11-10
PhosLo Fresenius Medical Care North America	Prescription Medication	2022-11-10
Velphoro Fresenius Medical Care North America, Vifor Fresenius Medical Care Renal Pharma France	Prescription Medication	2022-11-10
DELFLEX Fresenius Medical Care North America	Prescription Medication	2022-11-09
Sodium Chloride Fresenius Medical Care North America	Prescription Medication	2022-11-09
Sodium Chloride Fresenius Medical Care de Mexico, S.A. de C.V.	Prescription Medication	2022-11-09
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2022-11-09
DELFLEX Fresenius Medical Care North America	Prescription Medication	2022-11-09
DELFLEX Fresenius Medical Care North America	Prescription Medication	2022-07-29
DELFLEX Fresenius Medical Care North America	Prescription Medication	2022-07-29
Velphoro Fresenius Medical Care North America, Vifor Fresenius Medical Care Renal Pharma France	Prescription Medication	2021-12-31
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2021-11-16
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2021-11-16
DELFLEX Fresenius Medical Care North America	Prescription Medication	2021-11-04
DELFLEX Fresenius Medical Care North America	Prescription Medication	2021-11-04
DELFLEX Fresenius Medical Care North America	Prescription Medication	2021-11-04
PhosLo Fresenius Medical Care North America	Prescription Medication	2021-11-04
Sodium Chloride Fresenius Medical Care North America	Prescription Medication	2021-11-03
Sodium Chloride Fresenius Medical Care de Mexico, S.A. de C.V.	Prescription Medication	2021-11-03
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2021-10-30
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2021-10-28
DELFLEX Fresenius Medical Care North America	Prescription Medication	2021-07-31
DELFLEX Fresenius Medical Care North America	Prescription Medication	2021-07-02
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2021-05-20
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2021-05-08
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2021-03-26
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Medical Care North America	Prescription Medication	2021-03-23
Calcium Acetate Fresenius Medical Care North America	Prescription Medication	2021-03-11
DELFLEX Fresenius Medical Care North America	Prescription Medication	2021-02-10
DELFLEX Fresenius Medical Care North America	Prescription Medication	2021-02-10
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2021-02-02
LACTATED RINGERS Becton Dickinson and Company, Fresenius Kabi Norge As, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America	Prescription Medication	2021-01-31
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-12-31
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-12-31
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-11-19
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-11-19
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2020-11-07
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2020-11-07
Velphoro Fresenius Medical Care North America, Vifor Fresenius Medical Care Renal Pharma France	Prescription Medication	2020-11-07
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-11-05
Sodium Chloride Fresenius Medical Care North America	Prescription Medication	2020-11-04
PhosLo Fresenius Medical Care North America	Prescription Medication	2020-11-04
Sodium Chloride Fresenius Medical Care de Mexico, S.A. de C.V.	Prescription Medication	2020-10-29
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2020-10-08
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-09-22
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-09-22
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-07-24
DELFLEX Fresenius Medical Care North America	Prescription Medication	2020-07-24
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2020-06-13
Hand Sanitizer Fresenius Medical Care North America	Otc Medication	2020-05-07
Velphoro Fresenius Medical Care North America, Vifor Fresenius Medical Care Renal Pharma France	Prescription Medication	2020-04-24
Hand Sanitizer Fresenius Medical Care North America	Otc Medication	2020-04-14
Velphoro Fresenius Medical Care North America, Vifor Fresenius Medical Care Renal Pharma France	Prescription Medication	2020-04-08
Hand Sanitizer Fresenius Medical Care North America	Otc Medication	2020-04-07
Hand Sanitizer Fresenius Medical Care North America	Otc Medication	2020-03-31
NDC 49230-999 Fresenius Medical Care North America	Hand Sanitizer	2020-03-30
PMN K143617 \| FIP FRESENIUS MEDICAL CARE NORTH AMERICA	Aqua C UNO H	2020-03-13
PMN K133829 \| FIP FRESENIUS MEDICAL CARE NORTH AMERICA	AquaBplus	2020-03-13
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 K191474 \| KPO FRESENIUS MEDICAL CARE NORTH AMERICA	NaturaLyte Dry Bicarbonate Concentrate	2020-03-02
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2020-01-01
Sodium Chloride Fresenius Medical Care North America	Prescription Medication	2019-12-31
Sodium Chloride Fresenius Medical Care de Mexico, S.A. de C.V.	Prescription Medication	2019-12-31
Velphoro Fresenius Medical Care North America, Vifor Fresenius Medical Care Renal Pharma France	Prescription Medication	2019-12-10
DELFLEX Fresenius Medical Care North America	Prescription Medication	2019-11-06
DELFLEX Fresenius Medical Care North America	Prescription Medication	2019-11-06
Sodium Chloride Fresenius Medical Care North America	Prescription Medication	2019-11-06
Calcium Acetate Fresenius Medical Care North America	Prescription Medication	2019-11-06
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2019-11-06
Calcium Acetate Sandoz Inc, Fresenius Medical Care North America	Prescription Medication	2019-11-06
PhosLo Fresenius Medical Care North America	Prescription Medication	2019-11-06
DELFLEX Fresenius Medical Care North America	Prescription Medication	2019-11-01
Calcium Acetate Fresenius Medical Care North America	Prescription Medication	2019-10-25
Phoslyra Fresenius Medical Care North America, Lyne Laboratories, Inc., Niacet B.V.	Prescription Medication	2019-10-25
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 K190459 \| FJI FRESENIUS MEDICAL CARE NORTH AMERICA	Hemoflow F4 Dialyzer	2019-08-27
PMN K190459 \| FJI FRESENIUS MEDICAL CARE NORTH AMERICA	Hemoflow F3 Dialyzer	2019-08-27
PMN K182367 \| FIP FRESENIUS MEDICAL CARE NORTH AMERICA	DIASAFEplusUS	2019-01-11
NDC 49230-644 Fresenius Medical Care North America	Calcium Acetate	2018-12-01
PMN K181108 \| FKX FRESENIUS USA, INC. [Fresenius Medical Care North America]	Fresenius Liberty Select Cycler	2018-05-30
PMN K181108 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Liberty Select Cycler	2018-05-30
PMN K173593 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe to Luer-Lock Adapater	2018-05-24
PMN K173593 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Catheter Ext Set with Safe-Lock, 12	2018-05-24
PMN K173593 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Catheter Ext Set with Luer-Lock, 6	2018-05-24
PMN K173593 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Catheter Ext Set with Luer-Lock, 18	2018-05-24
PMN K173593 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Catheter Ext Set with Luer-Lock, 12	2018-05-24
PMN K173593 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe to Luer-Lock Adapater	2018-05-24
PMN K173593 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Safe-Lock, 12	2018-05-24
PMN K173593 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Luer-Lock, 6	2018-05-24
PMN K173593 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Luer-Lock, 18	2018-05-24
PMN K173593 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Luer-Lock, 12	2018-05-24
PMN K173593 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	StaySafe to Luer-Lock Adapater	2018-05-24
PMN K173593 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Safe-Lock, 12	2018-05-24
PMN K173593 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Luer-Lock, 6	2018-05-24
PMN K173593 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Luer-Lock, 18	2018-05-24
PMN K173593 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	StaySafe Catheter Ext Set with Luer-Lock, 12	2018-05-24
MON FRESENIUS MEDICAL CARE NORTH AMERICA	Dialyzer holder lock sleeve	2018-05-17
MON Denise Oppermann [Fresenius Medical Care North America]	Dialyzer holder lock sleeve	2018-05-17
PMN K173972 \| KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008T BlueStar Hemodialysis Machine	2018-05-15
PMN K173972 \| KDI FRESENIUS MEDICAL CARE NORTH AMERICA	2008T BlueStar Hemodialysis Machine	2018-05-15
PMN K173718 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Organizer	2018-05-15
PMN K173718 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Organizer Holder	2018-05-15
PMN K173718 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Handi-Tool	2018-05-15
PMN K173718 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	StaySafe Clip	2018-05-15
PMN K173718 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	Liberty Cycler Set	2018-05-15
PMN K173718 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Organizer	2018-05-15
PMN K173718 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Organizer Holder	2018-05-15
PMN K173718 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Handi-Tool	2018-05-15
PMN K173718 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	StaySafe Clip	2018-05-15
PMN K173718 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Liberty Cycler Set	2018-05-15
PMN K173718 \| FKX Denise Oppermann [Fresenius Medical Care North America]	StaySafe Organizer	2018-05-15
PMN K173718 \| FKX Denise Oppermann [Fresenius Medical Care North America]	StaySafe Organizer Holder	2018-05-15
PMN K173718 \| FKX Denise Oppermann [Fresenius Medical Care North America]	StaySafe Handi-Tool	2018-05-15
PMN K173718 \| FKX Denise Oppermann [Fresenius Medical Care North America]	StaySafe Clip	2018-05-15
PMN K173718 \| FKX Denise Oppermann [Fresenius Medical Care North America]	Liberty Cycler Set	2018-05-15
PMN K173651 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	stay safe Drain Set	2018-02-15
PMN K173651 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors	2018-02-15
PMN K173651 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	stay safe Drain Set	2018-02-15
PMN K173651 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors	2018-02-15
PMN K173651 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	stay safe Drain Set	2018-02-15
PMN K173651 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors	2018-02-15
PMN K173363 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	Cycler Drain Bag Set	2018-01-26
PMN K173363 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	Cycler Drain Bag Set	2018-01-26
PMN K172238 \| KOC FRESENIUS MEDICAL CARE NORTH AMERICA	CAREline Airless Hemodialysis Blood Tubing Sets	2017-12-19
PMN K172238 \| KOC Denise Oppermann [Fresenius Medical Care North America]	CAREline Airless Hemodialysis Blood Tubing Sets	2017-12-19
PMN K172238 \| FJK FRESENIUS MEDICAL CARE NORTH AMERICA	CAREline Airless Hemodialysis Blood Tubing Sets	2017-12-19
PMN K172238 \| FJK Denise Oppermann [Fresenius Medical Care North America]	CAREline Airless Hemodialysis Blood Tubing Sets	2017-12-19
PMN K171652 \| FKX FRESENIUS USA, INC. [Fresenius Medical Care North America]	Fresenius Liberty Select Cycler	2017-09-26
PMN K171652 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Liberty Select Cycler	2017-09-26
PMN K153449 \| KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K2 Hemodialysis Machine	2017-09-26
PMN K153449 \| KDI FRESENIUS MEDICAL CARE NORTH AMERICA	2008K2 Hemodialysis Machine	2017-09-26
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 K162716 \| KPO FRESENIUS MEDICAL CARE NORTH AMERICA	bibag 08-4080-BB (900g)	2017-06-15
PMN K162716 \| KPO 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 K162488 \| KDI FRESENIUS MEDICAL CARE NORTH AMERICA	Optiflux F160NR, F180NR, F200NR, F250NR Dialyzers	2017-05-09
PMN K162488 FRESENIUS MEDICAL CARE NORTH AMERICA	Optiflux Dialyzer	2017-04-06
ONW Denise Oppermann [Fresenius Medical Care North America]	Combiset Blood Line	2017-02-17
FKX Denise Oppermann [Fresenius Medical Care North America]	PD Cycler Set with 2 Triggers	2017-02-17
FKX Denise Oppermann [Fresenius Medical Care North America]	PD Cycler Set with 1 Trigger	2017-02-17
PMN K160749 \| KOC FRESENIUS MEDICAL CARE NORTH AMERICA	Crit-Line III Blood Chamber II	2016-07-21
PMN K152953 \| KOC FRESENIUS MEDICAL CARE NORTH AMERICA	Crit-Line Clip (CLiC) Blood Chamber	2016-01-26
PMN K152953 \| KOC ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Crit-Line Clip (CLiC) Blood Chamber	2016-01-26
PMN K152953 \| KOC Denise Oppermann [Fresenius Medical Care North America]	Crit-Line Clip (CLiC) Blood Chamber	2016-01-26
PMN K150708 \| ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K Hemodialysis Machine, 2008K@home Heomdialysis Machine, 2008T Hemodialysis, 2008T Hemodialysis Machine	2016-01-26
PMN K150708 \| ONW FRESENIUS MEDICAL CARE NORTH AMERICA	2008K Hemodialysis Machine, 2008K@home Heomdialysis Machine, 2008T Hemodialysis, 2008T Hemodialysis Machine	2016-01-26
PMN K150708 \| KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K Hemodialysis Machine, 2008K@home Heomdialysis Machine, 2008T Hemodialysis, 2008T Hemodialysis Machine	2016-01-26
PMN K150708 \| KDI FRESENIUS MEDICAL CARE NORTH AMERICA	2008K Hemodialysis Machine, 2008K@home Heomdialysis Machine, 2008T Hemodialysis, 2008T Hemodialysis Machine	2016-01-26
PMN K152953 FRESENIUS MEDICAL CARE NORTH AMERICA	CRIT-LINE CLIP (CLIC) BLOOD CHAMBER	2015-11-05
PMN K152367 FRESENIUS MEDICAL CARE NORTH AMERICA	Optiflux Dialyzer	2015-10-29
PMN K141997 \| KOC FRESENIUS USA, INC. [Fresenius Medical Care North America]	CritLine IV System	2015-04-29
PMN K141997 \| KOC FRESENIUS MEDICAL CARE NORTH AMERICA	CritLine IV System	2015-04-29
PMN K124024 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	APD Luer Lock Adapter	2015-02-27
PMN K124024 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	APD Luer Lock Adapter	2015-02-27
PMN K124024 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	APD Luer Lock Adapter	2015-02-27
PMN K124035 \| ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K124035 \| ONW FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K124035 \| ODX FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K124035 \| ODX FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K124035 \| KPO FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K124035 \| KPO FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K121421 \| ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K121421 \| ONW FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K121421 \| ODX FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K121421 \| ODX FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K121421 \| KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K121421 \| KDI FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K123262 FRESENIUS MEDICAL CARE NORTH AMERICA	OPTIFLUX ULTRA DIALYZER	2014-01-06
NDC 49230-645 Fresenius Medical Care North America	Velphoro	2013-11-27
PMN K131611 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS DRY ACID DISSOLUTION UNITS	2013-08-29
PMN K124035 FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@HOME HEMODIALYSIS MACHINE	2013-07-03
PMN K121341 FRESENIUS MEDICAL CARE, NORTH AMERICA	FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM	2012-12-06
PMN K121599 FRESENIUS MEDICAL CARE-NORTH AMERICA	CRIT-LINE CLIP (CLIC)	2012-11-09
PMN K120823 \| FJK FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set	2012-06-27
PMN K120823 \| FJK Denise Oppermann [Fresenius Medical Care North America]	Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set	2012-06-27
PMN K980659 \| KPO Fresenius USA Manufacturing, Inc. [Fresenius Medical Care North America]	DRYalysate Concentrate	2012-03-02
PMN K980659 \| KPO 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 K000792 \| KPO FRESENIUS MEDICAL CARE NORTH AMERICA	Citrasate Dialysate Acid Concentrate Liquid	2012-03-02
PMN K120017 FRESENIUS MEDICAL CARE, NORTH AMERICA	FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM	2012-02-02
PMN K113427 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS 2008T HEMODIALYSIS MACHINE	2011-12-21
PMN K935958 \| KOC FRESENIUS USA, INC. [Fresenius Medical Care North America]	CRITLINE BLOOD CHAMBER	2011-07-08
PMN K935958 \| KOC FRESENIUS MEDICAL CARE NORTH AMERICA	CRITLINE BLOOD CHAMBER	2011-07-08
PMN K011741 \| MQS FRESENIUS USA, INC. [Fresenius Medical Care North America]	Crit-line III TQa URR Monitor	2011-07-08
PMN K011741 \| MQS FRESENIUS MEDICAL CARE NORTH AMERICA	Crit-line III TQa URR Monitor	2011-07-08
PMN K011741 \| FIL FRESENIUS USA, INC. [Fresenius Medical Care North America]	Crit-line III TQa URR Monitor	2011-07-08
PMN K011741 \| FIL FRESENIUS MEDICAL CARE NORTH AMERICA	Crit-line III TQa URR Monitor	2011-07-08
PMN K070049 \| ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
PMN K070049 \| ONW FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
PMN K070049 \| ONW Denise Oppermann [Fresenius Medical Care North America]	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
PMN K070049 \| ODX FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
PMN K070049 \| ODX FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
PMN K070049 \| ODX Denise Oppermann [Fresenius Medical Care North America]	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
NDC 49230-643 Fresenius Medical Care North America	Phoslyra	2011-04-15
PMN K070049 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR	2011-02-03
PMN K093902 FRESENIUS MEDICAL CARE NORTH AMERICA	MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573	2010-05-27
PMN K915628 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	LIBERTY DRAIN LINE LUER TAPE	2009-07-16
PMN K915628 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	LIBERTY DRAIN LINE LUER TAPE	2009-07-16
PMN K915628 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	LIBERTY DRAIN LINE LUER TAPE	2009-07-16
PMN K822550 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Safe-Lock catheter adapter Co-Pack II	2009-07-16
PMN K822550 \| FKX Denise Oppermann [Fresenius Medical Care North America]	Safe-Lock catheter adapter Co-Pack II	2009-07-16
PMN K822546 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	CATHETER ADAPTER SEALING CAP	2009-07-16
PMN K822546 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	CATHETER ADAPTER SEALING CAP	2009-07-16
PMN K822546 \| FKX Denise Oppermann [Fresenius Medical Care North America]	CATHETER ADAPTER SEALING CAP	2009-07-16
PMN K822543 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Universal connector	2009-07-16
PMN K822543 \| FKX Denise Oppermann [Fresenius Medical Care North America]	Universal connector	2009-07-16
PMN K811986 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	4 LEAD ECO PREFILLED W/SNAP DISCONNECT	2009-07-16
PMN K811986 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	4 LEAD ECO PREFILLED W/SNAP DISCONNECT	2009-07-16
PMN K811986 \| FKX Denise Oppermann [Fresenius Medical Care North America]	4 LEAD ECO PREFILLED W/SNAP DISCONNECT	2009-07-16
PMN K080964 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE	2009-01-14
PMN K083542 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Sterile Stay Safe Cap	2008-12-30
PMN K083542 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Fresenius Sterile Stay Safe Cap	2008-12-30
PMN K083542 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	Fresenius Sterile Stay Safe Cap	2008-12-30
PMN K083542 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS STERILE STAY SAFE CAP	2008-12-29
PMN K082414 FRESENIUS MEDICAL CARE NORTH AMERICA	OPTIFLUX F250NR, MODEL 0500325E	2008-10-28
PMN K955762 \| KPF FRESENIUS USA, INC. [Fresenius Medical Care North America]	PACK-PD Peritoneal Dialysis Urea Kinetic Modeling Software Program	2008-03-18
PMN K955762 \| KPF FRESENIUS MEDICAL CARE NORTH AMERICA	PACK-PD Peritoneal Dialysis Urea Kinetic Modeling Software Program	2008-03-18
PMN K002892 \| FKX FRESENIUS USA, INC. [Fresenius Medical Care North America]	Fresenius PD+ IQ Card Cycler	2008-03-18
PMN K002892 \| FKX FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius PD+ IQ Card Cycler	2008-03-18
PMN K002892 \| FKX ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Fresenius PD+ IQ Card Cycler	2008-03-18
PMN K002892 \| FKX Denise Oppermann [Fresenius Medical Care North America]	Fresenius PD+ IQ Card Cycler	2008-03-18
PMN K962081 \| FJK FRESENIUS MEDICAL CARE NORTH AMERICA	Combilines Hemodialysis Blood Tubing Set	2008-03-05
PMN K962081 \| FJK Denise Oppermann [Fresenius Medical Care North America]	Combilines Hemodialysis Blood Tubing Set	2008-03-05
PMN K921134 \| KDI FRESENIUS MEDICAL CARE NORTH AMERICA	Hemoflow F40S	2008-01-08
PMN K904806 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	CAPD SAFE LOCK TRANSFER SET, STAY SAFE DRAIN SET	2008-01-08
PMN K904806 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	CAPD SAFE LOCK TRANSFER SET, STAY SAFE DRAIN SET	2008-01-08
PMN K904806 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	CAPD SAFE LOCK TRANSFER SET, STAY SAFE DRAIN SET	2008-01-08
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 K870725 \| FJI FRESENIUS MEDICAL CARE NORTH AMERICA	Hemoflow F8 Dialyzer	2008-01-08
PMN K870725 \| FJI 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 K070177 \| KPO FRESENIUS MEDICAL CARE NORTH AMERICA	Naturalyte Liquid or Powder	2008-01-08
PMN K041042 \| FPA FRESENIUS MEDICAL CARE NORTH AMERICA	Split Septum Injection Sites	2008-01-08
PMN K041042 \| FPA Denise Oppermann [Fresenius Medical Care North America]	Split Septum Injection Sites	2008-01-08
PMN K022536 \| KOC FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Standalone Access Flow Reserving Connector	2008-01-08
PMN K022536 \| KOC Denise Oppermann [Fresenius Medical Care North America]	Fresenius Standalone Access Flow Reserving Connector	2008-01-08
PMN K022412 \| KDJ FRESENIUS MEDICAL CARE NORTH AMERICA	CAPD Staysafe Disposable Adminstration Sets with Staysafe Connector	2008-01-08
PMN K022412 \| KDJ ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	CAPD Staysafe Disposable Adminstration Sets with Staysafe Connector	2008-01-08
PMN K022412 \| KDJ Denise Oppermann [Fresenius Medical Care North America]	CAPD Staysafe Disposable Adminstration Sets with Staysafe Connector	2008-01-08
PMN K010268 \| KOC FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Priming Set with Needless Access Port	2008-01-08
PMN K010268 \| KOC Denise Oppermann [Fresenius Medical Care North America]	Fresenius Priming Set with Needless Access Port	2008-01-08
PMN K003445 \| FIB FRESENIUS MEDICAL CARE NORTH AMERICA	Transducer Protectors	2008-01-08
PMN K003445 \| FIB Denise Oppermann [Fresenius Medical Care North America]	Transducer Protectors	2008-01-08
PMN K001873 \| FJK FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Bloodlines Patient Connector (HemaClip)	2008-01-08
PMN K001873 \| FJK ERIKA DE REYNOSA, S.A. DE C.V. [Fresenius Medical Care North America]	Fresenius Bloodlines Patient Connector (HemaClip)	2008-01-08
PMN K001873 \| FJK Denise Oppermann [Fresenius Medical Care North America]	Fresenius Bloodlines Patient Connector (HemaClip)	2008-01-08
PMN K001107 \| FJK FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Combilines Blood Tubing Set	2008-01-08
PMN K001107 \| FJK Denise Oppermann [Fresenius Medical Care North America]	Fresenius Combilines Blood Tubing Set	2008-01-08
PMN K000451 \| FJK FRESENIUS MEDICAL CARE NORTH AMERICA	Fresenius Combilines Single Needle Blood Tubing Set	2008-01-08
PMN K000451 \| FJK Denise Oppermann [Fresenius Medical Care North America]	Fresenius Combilines Single Needle Blood Tubing Set	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 K030497 \| KPO FRESENIUS MEDICAL CARE NORTH AMERICA	GranuFlo Dry Acid Concentrate	2007-11-28
PMN K071387 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB	2007-06-15
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
PMN K981043 \| KPO FRESENIUS MEDICAL CARE NORTH AMERICA	NaturaLyte Liquid Acid Concentrate	2007-05-22
PMN K070222 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N	2007-04-24
NDC 49230-300 Fresenius Medical Care North America	Sodium Chloride	2007-04-12
NDC 46163-300 Fresenius Medical Care North America	Sodium Chloride	2007-04-12
PMN K070177 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES	2007-03-29
PMN K944767 \| FIP FRESENIUS MEDICAL CARE NORTH AMERICA	Diasafe Plus Ultrafilter	2006-09-14
PMN K060734 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)	2006-09-05
PMN K050273 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS ART HEMOADSORPTION SYSTEM	2005-06-08
PMN K043363 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS LIBERTY CYCLER	2005-03-31
PMN K043244 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR	2004-12-20
PMN BK040076 Fresenius Medical Care North America	Transfer Sets	2004-12-17
PMN K041792 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211	2004-09-24
PMN K041042 FRESENIUS MEDICAL CARE NORTH AMERICA	SPLIT SEPTUM INJECTION SITES	2004-07-16
PMN BK040005 Fresenius Medical Care North America	Blood Mixing And Weighing Devices	2004-03-26
PMN BK030022 Fresenius Medical Care North America	Blood Bank Supplies	2003-07-11
PMN K031378 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS ULTRAFLUX HEMODIALYZER	2003-05-30
PMN K022412 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR	2003-03-05
PMN K021060 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS ICARE MONITORING SYSTEM	2002-11-13
PMN K012242 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS	2001-08-16
PMN K010268 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9	2001-04-27
PMN K002892 FRESENIUS MEDICAL CARE NORTH AMERICA	FRSENIUS PD IQCARD CYCLER	2001-04-05
NDC 49230-640 Fresenius Medical Care North America	PhosLo	2001-04-02
PMN K003498 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS OPTIFLUX 200A	2001-01-04
PMN K002761 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS	2000-12-04
PMN K003445 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2	2000-12-01
PMN K002277 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS OPTIFLUX 200NR	2000-08-25
PMN K001873 FRESENIUS MEDICAL CARE NORTH AMERICA	HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0	2000-07-28
PMN K001107 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)	2000-06-23
PMN K000702 FRESENIUS MEDICAL CARE NORTH AMERICA	BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR	2000-06-07
PMN K000451 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290	2000-05-09
PMN K982926 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS BLOOD VOLUME MONITOR	1999-09-03
PMN K991520 FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION	1999-07-30
PMN K974090 FRESENIUS MEDICAL CARE NORTH AMERICA	95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS	1998-08-27
NDC 49230-212 Fresenius Medical Care North America	DELFLEX	1992-08-19
NDC 49230-209 Fresenius Medical Care North America	DELFLEX	1992-08-19
NDC 49230-206 Fresenius Medical Care North America	DELFLEX	1992-08-19
NDC 49230-203 Fresenius Medical Care North America	DELFLEX	1984-11-30
NDC 49230-200 Fresenius Medical Care North America	DELFLEX	1984-11-30
NDC 49230-197 Fresenius Medical Care North America	DELFLEX	1984-11-30
NDC 49230-194 Fresenius Medical Care North America	DELFLEX	1984-11-30
NDC 49230-191 Fresenius Medical Care North America	DELFLEX	1984-11-30
NDC 49230-188 Fresenius Medical Care North America	DELFLEX	1984-11-30

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