SSU-D with Orifice

GUDID 10896241002500

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 with other water treatment equipment (RO, DI, 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 ID10896241002500
NIH Device Record Keybd7856b3-b18f-480c-851d-071fb6c26b44
Commercial Distribution StatusIn Commercial Distribution
Brand NameSSU-D with Orifice
Version Model Number70-0243O
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
GS100896241002503 [Primary]
GS110896241002500 [Package]
Contains: 00896241002503
Package: Carton [10 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 Date2016-09-24

Devices Manufactured by NEPHROS, INC.

10896241002258 - SSU Dome Thread Dialysis2021-09-14 The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in
10896241002500 - SSU-D with Orifice2021-09-14The 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 with other water treatment equipment (RO, DI, etc.).
10896241002500 - SSU-D with Orifice2021-09-14 The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in
00896241002541 - S100 Sink Spout2021-09-14 The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter ret
10896241002555 - S100 Sink Spray2021-09-14 The S100 Point of Use Filter is a disposable point of use micro-filter used to filter EPA quality drinking water. The filter ret
10896241002562 - S100 Handheld thread2021-09-14 The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter ret
20896241002668 - EndoPur Endotoxin 30" Filter 2021-09-14 Intended Use: The EndoPur Endotoxin 30” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
20896241002675 - EndoPur Endotoxin 40" Filter 2021-09-14 Intended Use: The EndoPur Endotoxin 40” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
10896241002210 - SSU Dome Dialysis2021-05-21 SSU Dome Dialysis and packaging information

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