SSU-H Thread

GUDID 10896241002333

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 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.

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
Primary Device ID10896241002333
NIH Device Record Key86a53dbc-aa2b-44f9-ba8a-fb6423622795
Commercial Distribution StatusIn Commercial Distribution
Brand NameSSU-H Thread
Version Model Number70-0284
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 Usefalse
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
GS100896241002336 [Primary]
GS110896241002333 [Package]
Contains: 00896241002336
Package: Carton Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHVSystem, Water Purification, General Medical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-09-17
Device Publish Date2016-09-24

On-Brand Devices [SSU-H Thread]

10896241002333The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking
10896241002401The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking

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