SSU Dome Thread Dialysis

GUDID 10896241002258

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 ID10896241002258
NIH Device Record Key3fffe717-0c7d-44c8-8429-cc7baaf99596
Commercial Distribution StatusIn Commercial Distribution
Brand NameSSU Dome Thread Dialysis
Version Model Number70-0244D
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
GS100896241002251 [Primary]
GS110896241002258 [Package]
Contains: 00896241002251
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.

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10896241002067 - H2H Infusion Set2021-09-17 H2H Infusion Set and packaging information
10896241002074 - H2H Substitution Filter2021-09-17 H2H Substitution Filter and packaging information
10896241002081 - H2H Water Filter2021-09-17 H2H Water Filter and packaging information
10896241002326 - SSU-H Quick Connect2021-09-17 The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
10896241002333 - SSU-H Thread2021-09-17 The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
10896241002364 - H2H Rinse Line2021-09-17 H2H Rinse Line and packaging information
10896241002586 - S100 Handheld quick connect2021-09-17 S100 Handheld quick connect and packaging information

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