Nephros Inc

FDA Filings

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

USA

NASDAQ

NEPH

DUNS 120664557

FDA Registration(s)

• Registration Number: 3003337893
• FEI Number: 3003337893
• Name: NEPHROS, INC.
• Owner & Operator: NEPHROS, INC.
• Contact Address: 380 Lakawana Place ; South Orange NJ 07079 US
• Official Correspondent:
  • Vashone R Thomas
  • x-201-3450829-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 380 Lackawana Place ; South Orange, NJ 07079 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00896241002732 NEPHROS, INC.	MarCor ENX Hollow Fiber Capsule UltraFilter 70-0251M	2024-02-14
GUDID 10896241002104 NEPHROS, INC.	DSU-H Thread (Polyproplyene)	2022-03-21
GUDID 10896241002098 NEPHROS, INC.	DSU-H Quick Connect (Polypropylene)	2022-03-21
GUDID 10896241002685 NEPHROS, INC.	EndoPur Endotoxin 20" Filter	2021-09-24
GUDID 10896241002609 NEPHROS, INC.	S100 Sink Spray	2021-09-24
GUDID 10896241002579 NEPHROS, INC.	S100 Handheld thread	2021-09-24
GUDID 10896241002531 NEPHROS, INC.	S100 Sink Spout	2021-09-24
GUDID 10896241002517 NEPHROS, INC.	SSU-D with Orifice	2021-09-24
GUDID 10896241002401 NEPHROS, INC.	SSU-H Thread	2021-09-24
GUDID 10896241002388 NEPHROS, INC.	DSU-H Quick Connect	2021-09-24
GUDID 10896241002371 NEPHROS, INC.	DSU-H Thread	2021-09-24
GUDID 10896241002319 NEPHROS, INC.	SSU-H Quick Connect	2021-09-24
GUDID 10896241002227 NEPHROS, INC.	SSU Dome Dialysis	2021-09-24
GUDID 10896241002135 NEPHROS, INC.	DSU Dome Dialysis	2021-09-24
GUDID 10868277000454 NEPHROS, INC.	TQE Plus Endotoxin 20" Filter Flat 222 Head	2021-09-24
GUDID 10868277000447 NEPHROS, INC.	TQE Plus Endotoxin 10" Filter Flat 222 Head	2021-09-24
GUDID 10866318000388 NEPHROS, INC.	EndoPur Endotoxin 10" Filter	2021-09-24
GUDID 20896241002057 NEPHROS, INC.	OLpur MD 220 - FDA	2021-09-17
GUDID 10896241002586 NEPHROS, INC.	S100 Handheld quick connect	2021-09-17
GUDID 10896241002364 NEPHROS, INC.	H2H Rinse Line	2021-09-17
GUDID 10896241002333 NEPHROS, INC.	SSU-H Thread	2021-09-17
GUDID 10896241002326 NEPHROS, INC.	SSU-H Quick Connect	2021-09-17
GUDID 10896241002081 NEPHROS, INC.	H2H Water Filter	2021-09-17
GUDID 10896241002074 NEPHROS, INC.	H2H Substitution Filter	2021-09-17
GUDID 10896241002067 NEPHROS, INC.	H2H Infusion Set	2021-09-17
GUDID 20896241002675 NEPHROS, INC.	EndoPur Endotoxin 40" Filter	2021-09-14
GUDID 20896241002668 NEPHROS, INC.	EndoPur Endotoxin 30" Filter	2021-09-14
GUDID 10896241002562 NEPHROS, INC.	S100 Handheld thread	2021-09-14
GUDID 10896241002555 NEPHROS, INC.	S100 Sink Spray	2021-09-14
GUDID 10896241002500 NEPHROS, INC.	SSU-D with Orifice	2021-09-14
GUDID 10896241002258 NEPHROS, INC.	SSU Dome Thread Dialysis	2021-09-14
GUDID 00896241002541 NEPHROS, INC.	S100 Sink Spout	2021-09-14
GUDID 10896241002210 NEPHROS, INC.	SSU Dome Dialysis	2021-05-21
GUDID 10896241002128 NEPHROS, INC.	DSU Dome Dialysis	2021-04-15
GUDID 10896241002593 NEPHROS, INC.	SSUmini JG	2021-02-10
GUDID 10896241002357 NEPHROS, INC.	DSU-H Thread	2021-02-10
GUDID 10896241002340 NEPHROS, INC.	DSU-H Quick Connect	2021-02-10
GUDID 10896241002203 NEPHROS, INC.	SSUmini thread	2021-02-10
GUDID 20868277000437 NEPHROS, INC.	TQE Plus Endotoxin 30" Filter Flat 222 Head	2020-08-24
GUDID 10868277000423 NEPHROS, INC.	TQE Plus Endotoxin 20" Filter Flat 222 Head	2020-08-24
GUDID 10868277000416 NEPHROS, INC.	TQE Plus Endotoxin 10" Filter Flat 222 Head	2020-08-24
GUDID 20866318000354 NEPHROS, INC.	EndoPur Endotoxin 10" Filter Flat	2020-01-20
GUDID 20866318000378 NEPHROS, INC.	EndoPur Endotoxin 20" Filter	2018-11-15
GUDID 20866318000361 NEPHROS, INC.	EndoPur Endotoxin 10" Filter Fin	2018-11-15
GUDID 20866318000358 NEPHROS, INC.	EndoPur Endotoxin 10" Filter Flat	2018-11-15
GUDID 20866318000347 NEPHROS, INC.	HydraGuard 10" UltraFilter - Flush	2018-11-15
GUDID 20866318000330 NEPHROS, INC.	HydraGuard 10” UltraFilter - Flushable	2018-11-15
GUDID 10866318000326 NEPHROS, INC.	HydraGuard 10" UltraFilter	2018-11-15
GUDID 10866318000302 NEPHROS, INC.	SSUmini JG 3/8	2018-11-15
GUDID 02086827700062 NEPHROS, INC.	TQE Plus Endotoxin 30" Filter Flat 222 Head	2018-11-15
GUDID 02086827700048 NEPHROS, INC.	TQE Plus Endotoxin 10" Filter Flat 222 Head	2018-11-15
GUDID 01086827700056 NEPHROS, INC.	TQE Plus Endotoxin 20" Filter Flat 222 Head	2018-11-15
PMN K161304 | FIP NEPHROS, INC.	TQE Plus Endotoxin 30" Filter Flat 222 Head	2017-04-06
PMN K161304 | FIP NEPHROS, INC.	TQE Plus Endotoxin 20" Filter Flat 222 Head	2017-04-06
PMN K161304 | FIP NEPHROS, INC.	TQE Plus Endotoxin 10" Filter Flat 222 Head	2017-04-06
PMN K161304 | FIP NEPHROS, INC.	EndoPur Endotoxin 30" Filter	2017-04-06
PMN K161304 | FIP NEPHROS, INC.	EndoPur Endotoxin 20" Filter	2017-04-06
PMN K161304 | FIP NEPHROS, INC.	EndoPur Endotoxin 10" Filter Flat	2017-04-06
PMN K161304 Nephros Inc.	EndoPur Filter	2017-03-02
PMN K161467 | NHV NEPHROS, INC.	HydraGuard 10? UltraFilter - Flushable	2017-02-28
PMN K161467 | NHV NEPHROS, INC.	HydraGuard 10" UltraFilter	2017-02-28
PMN K161467 NEPHROS INC.	HydraGuard 10 UltraFilter	2016-12-22
PMN K153084 | NHV NEPHROS, INC.	S100 Handheld Quick Connect	2016-09-19
PMN K153084 | NHV NEPHROS, INC.	S100 - Sink Spray	2016-09-19
PMN K153084 | NHV NEPHROS, INC.	S100 - Sink Spout	2016-09-19
PMN K153084 | NHV NEPHROS, INC.	S100 - Handheld Thread	2016-09-19
PMN K153084 NEPHROS INC.	Nephros S100	2016-04-08
PMN K141731 | NHV NEPHROS, INC.	SSU-H Ultrafilter	2015-12-02
PMN K141731 | NHV NEPHROS, INC.	DSU-H Ultrafilter	2015-12-02
PMN K141731 NEPHROS, INC.	NEPHROS DSU-H, NEPHROS SSU-H	2014-10-24
PMN K112314 | KDI NEPHROS, INC.	OLpur MD220 Hemodiafiltration Filter	2012-12-20
PMN K112314 | KDI NEPHROS, INC.	OLpur H2H Hemodiafiltration Module	2012-12-20
PMN K112314 | KDI NEPHROS, INC.	Nephros On-Line Mid-Dilution Hemodiafiltration System	2012-12-20
PMN K112314 | KDI NEPHROS, INC.	H2H Water Filter	2012-12-20
PMN K112314 | KDI NEPHROS, INC.	H2H Substitution Filter	2012-12-20
PMN K112314 | KDI NEPHROS, INC.	H2H Rinse Line	2012-12-20
PMN K112314 | KDI NEPHROS, INC.	H2H Infusion Set	2012-12-20
PMN K112314 NEPHROS, INC.	NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER	2012-04-27
PMN K110285 | FIP NEPHROS, INC.	SSU-D	2011-12-21
PMN K110285 | FIP NEPHROS, INC.	SSU Mini	2011-12-21
PMN K110285 | FIP NEPHROS, INC.	SSU Mini JG	2011-12-21
PMN K110285 | FIP NEPHROS, INC.	MSU	2011-12-21
PMN K110285 | FIP NEPHROS, INC.	ENRO-M-0.005 Micron Absolute	2011-12-21
PMN K110285 | FIP NEPHROS, INC.	DSU-D	2011-12-21
PMN K110285 NEPHROS, INC.	NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER	2011-07-14
PMN K090885 NEPHROS, INC.	NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER	2009-06-29
PMN K050603 NEPHROS, INC.	OLPUR DIALYZER, MODEL HD 190	2005-06-09

Related Finance Registrations

NCAGE Code	4SXV7	NEPHROS, INC.!DBA NEPHROS
CAGE Code	4SXV7	NEPHROS, INC. NEPHROS
S.A.M. Registration	4SXV7 [120664557]	NEPHROS, INC. NEPHROS
SEC	0001196298	NEPHROS INC of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020083171446	Livorno,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENTHS CODE: 84212100	11 PKG
2020081157237	Livorno,Italy -> New York/Newark Area, Newark, New Jersey	(PALLETS)MEDICAL EQUIPMENT HS CODE: 84212100	11 PKG
2020061575261	Livorno,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE: 84212100	11 PKG
2020052548784	Livorno,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE: 84212100	12 PKG
2020051128447	Livorno,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENTHS CODE: 84212100	11 PKG
2019072244078	Genova,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	5 PKG
2019070157230	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	(513 PACKAGES) MEDICAL EQUIPMENT HS CODE: 842 12100	10 PKG