nephros.comHDF Assist Mudule, HDF Infusion Set And Substitution Filter
Nephros
NEPHROS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003337893 | 3003337893 | NEPHROS, INC. | 1 | N | 2026-01-01 | 380 Lackawana Place South Orange NJ US 07079 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00896241002237 | Nephros SSUmini UltraFilter - The Nephros SSUmini UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must beused in conjunction with other water treatment equipment (RO, DI, etc.). | 201-345-0829 | vashone.thomas@nephros.com |
| 00896241002244 | Nephros SSUmini UltraFiltro - The Nephros SSUmini UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must beused in conjunction with other water treatment equipment (RO, DI, etc.). | 201-345-0829 | vashone.thomas@nephros.com |
| 00896241002626 | Nephros SSUmini JG UltraFiltro - The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used inconjunction with other water treatment equipment (RO, DI, etc.). | 201-345-0829 | vashone.thomas@nephros.com |
| 10896241002616 | Nephros SSUmini JG UltraFilter - The Nephros SSUmini JG UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.). | 201-345-0829 | vashone.thomas@nephros.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 61231 | 1222729345 | K161467 | HydraGuard 10 UltraFilter | NHV | 2016-12-22 |
| 61231 | 1713595855 | K161304 | EndoPur Filter | FIP | 2017-03-02 |
| 61231 | 1182691185 | K153084 | Nephros S100 | NHV | 2016-04-08 |
| 61231 | 1017053022 | K141731 | NEPHROS DSU-H, NEPHROS SSU-H | NHV | 2014-10-24 |
| 61231 | 1776506717 | K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER | KDI | 2012-04-27 |
| 61231 | 1031858223 | K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | FIP | 2011-07-14 |
Product Codes Associated With Registrations#
PMN#
EndoPur Filter
Nephros Inc.
HydraGuard 10 UltraFilter
NEPHROS INC.
Nephros S100
NEPHROS INC.
NEPHROS DSU-H, NEPHROS SSU-H
NEPHROS, INC.
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
NEPHROS, INC.
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
NEPHROS, INC.
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
NEPHROS, INC.
OLPUR DIALYZER, MODEL HD 190
NEPHROS, INC.
GUDID#
MarCor ENX Hollow Fiber Capsule UltraFilter - The MarCor ENX Hollow Fiber Capsule UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it.CONTRAINDICATIONSMedical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used.Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.
2017-07-18
Nephros SSUmini JG UltraFiltro - The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
2024-02-13
Nephros SSUmini JG UltraFilter - The Nephros SSUmini JG UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
2024-02-13
Nephros SSUmini UltraFiltro - The Nephros SSUmini UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must beused in conjunction with other water treatment equipment (RO, DI, etc.).
2024-02-13
Nephros SSUmini UltraFilter - The Nephros SSUmini UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must beused in conjunction with other water treatment equipment (RO, DI, etc.).
2024-02-13
"EndoPur Endotoxin 40"" Filter " - Intended Use: The EndoPur Endotoxin 40” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 40” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
2017-07-18
"EndoPur Endotoxin 30"" Filter " - Intended Use: The EndoPur Endotoxin 30” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 30” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
2017-07-18
Nephros SSUmini JG UltraFiltro - The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used inconjunction with other water treatment equipment (RO, DI, etc.).
2024-02-13
Nephros SSUmini JG UltraFilter - The Nephros SSUmini JG UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used inconjunction with other water treatment equipment (RO, DI, etc.).
2024-02-13
SSUmini JG - The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used inconjunction with other water treatment equipment (RO, DI, etc.).
2016-09-24
SSU-D with Orifice - The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
2021-09-16
SSU-D with Orifice - The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
2016-09-24
SSU Dome Thread Dialysis - The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
2016-09-24
Nephros SSU-D UltraFilter - The Nephros SSU-D UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
2021-09-16
SSU Dome Dialysis - The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
2016-09-24
SSUmini thread - SSUmini thread and packaging information
2016-09-24
Nephros DSU-D UltraFilter - The Nephros DSU-D UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
2021-09-16
DSU Dome Dialysis - The Nephros DSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
2016-09-22
"EndoPur Endotoxin 20"" Filter " - Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
2017-07-18
"EndoPur Endotoxin 10"" Filter Fin" - Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 10” Filter Fin is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
2017-09-29
"EndoPur Endotoxin 10"" Filter" - Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
2017-07-18
SSUmini JG 3/8 - The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. Itassists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
2017-12-31
"Filtro de Endotoxina Nephros EndoPur (plano) 20""" - "Intended Use: The Filtro de Endotoxina Nephros EndoPur (plano) 20"" is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.)."
2024-02-13
"Filtro de Endotoxina Nephros EndoPur (plano) 10""" - "Intended Use: The Filtro de Endotoxina Nephros EndoPur (plano) 10"" is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.)."
2024-02-13
S100 Sink Spout - The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2016-09-22
Nephros EndoPur Endotoxin 20” Filter Flat - Intended Use: The Nephros EndoPur Endotoxin 20” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
2021-09-16
Nephros S100 Sink Spray - The Nephros S100 Sink Spray is a disposable point of use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2021-09-16
Nephros S100 Shower Handheld - The Nephros S100 Shower Handheld is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medicalprocedures and washing of surgeon’s hands.
2021-09-16
S100 Handheld thread - The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medicalprocedures and washing of surgeon’s hands.
2016-09-22
S100 Sink Spray - The S100 Point of Use Filter is a disposable point of use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2016-09-22
Nephros S100 Sink Spout - The Nephros S100 Sink Spout is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2021-09-16
Nephros SSU-H UltraFilter - The Nephros SSU-H UltraFilter is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2021-09-16
Nephros DSU-H UltraFilter - The Nephros DSU-H UltraFilter is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapure water for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2021-09-16
Nephros DSU-H UltraFilter - The Nephros DSU-H UltraFilter is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapure water for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2021-09-16
DSU-H Thread - The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapurewater for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2016-09-24
DSU-H Quick Connect - The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapurewater for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2016-09-24
SSU-H Thread - The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapurewater for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2016-09-24
SSU-H Quick Connect - The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapurewater for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2016-09-24
Nephros SSU-H UltraFilter - The Nephros SSU-H UltraFilter is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2021-09-16
DSU-H Thread (Polyproplyene) - The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapurewater for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
2022-03-11