Nephros SSUmini UltraFiltro

GUDID 00896241002244

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 be used in conjunction with other water treatment equipment (RO, DI, etc.).

NEPHROS, INC.

Microbial water purification filter, non-sterilizable
Primary Device ID00896241002244
NIH Device Record Key29465028-a1b1-4d85-a714-c5c4f145dff6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNephros SSUmini UltraFiltro
Version Model Number70-0242P
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100896241002244 [Primary]
GS110896241002241 [Package]
Package: Filter Box [1 Units]
In Commercial Distribution
GS120896241002248 [Package]
Contains: 10896241002241
Package: Carton Box [10 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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-11
Device Publish Date2024-02-13

Devices Manufactured by NEPHROS, INC.

00896241002237 - Nephros SSUmini UltraFilter2024-11-11 The Nephros SSUmini UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices.
00896241002244 - Nephros SSUmini UltraFiltro2024-11-11The 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 be used in conjunction with other water treatment equipment (RO, DI, etc.).
00896241002244 - Nephros SSUmini UltraFiltro2024-11-11 The Nephros SSUmini UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices.
10896241002616 - Nephros SSUmini JG UltraFilter2024-11-11 The Nephros SSUmini JG UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis device
10896241002623 - Nephros SSUmini JG UltraFiltro2024-11-11 The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis device
00896241002732 - MarCor ENX Hollow Fiber Capsule UltraFilter2024-02-14 The MarCor ENX Hollow Fiber Capsule UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodi
10896241002098 - DSU-H Quick Connect (Polypropylene)2022-03-21 The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
10896241002104 - DSU-H Thread (Polyproplyene)2022-03-21 The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
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

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