SSUmini JG - The Nephros SSUmini is intended to be used to - NEPHROS, INC.

Duns Number:120664557

Device Description: The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used The Nephros SSUmini 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 inconjunction with other water treatment equipment (RO, DI, etc.).

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

SSUmini JG

Version/Model Number

70-0251

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Device Record Status

Public Device Record Key

69e0ab78-ba08-438a-bf9d-fda9df2e44ad

Public Version Date

September 14, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10896241002593

Quantity per Package

24

Contains DI Package

00896241002596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box

"NEPHROS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25