EndoPur Endotoxin 20" Filter

GUDID 10896241002685

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.).

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 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 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 Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable Microbial water purification filter, non-sterilizable
Primary Device ID10896241002685
NIH Device Record Keydb0cc438-a00d-4b98-b6e2-404338c665eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPur Endotoxin 20" Filter
Version Model Number70-0120H
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

Customer Support Contacts

Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100896241002688 [Primary]
GS110896241002685 [Package]
Contains: 00896241002688
Package: Filter Box [1 Units]
In Commercial Distribution
GS120896241002682 [Package]
Package: Carton Box [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

On-Brand Devices [EndoPur Endotoxin 20" Filter ]

20866318000378Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bac
10896241002685Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bac
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