EndoPur Endotoxin 30" Filter

GUDID 20896241002668

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.).

NEPHROS, INC.

Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable
Primary Device ID20896241002668
NIH Device Record Key28e29b9d-75dc-46ac-9643-fbb44648aa7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPur Endotoxin 30" Filter
Version Model Number70-0130
Company DUNS120664557
Company NameNEPHROS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100896241002664 [Primary]
GS110896241002661 [Package]
Contains: 00896241002664
Package: Filter Box [1 Units]
In Commercial Distribution
GS120896241002668 [Package]
Contains: 10896241002661
Package: Carton Box [15 Units]
In Commercial Distribution

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-14
Device Publish Date2017-07-18

Devices Manufactured by NEPHROS, INC.

10866318000388 - EndoPur Endotoxin 10" Filter2021-09-24 Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from flu
10868277000447 - TQE Plus Endotoxin 10" Filter Flat 222 Head2021-09-24 The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
10868277000454 - TQE Plus Endotoxin 20" Filter Flat 222 Head2021-09-24 The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
10896241002135 - DSU Dome Dialysis2021-09-24 The Nephros DSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in
10896241002227 - SSU Dome Dialysis2021-09-24 The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in
10896241002319 - SSU-H Quick Connect2021-09-24 The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
10896241002371 - DSU-H Thread2021-09-24 The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
10896241002388 - DSU-H Quick Connect2021-09-24 The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter

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