DSU Dome Dialysis - The Nephros DSU-D is intended to be used to - NEPHROS, INC.

Duns Number:120664557

Device Description: The Nephros DSU-D is intended to be used to filter water or bicarbonate concentrate used i The Nephros DSU-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 withother water treatment equipment (RO, DI, etc.).

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More Product Details

Catalog Number

-

Brand Name

DSU Dome Dialysis

Version/Model Number

70-0235D

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

-

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

abaa5ff7-c7b5-4f8a-99af-d20251c75c01

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Additional Identifiers

Package DI Number

10896241002135

Quantity per Package

1

Contains DI Package

00896241002138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Filter 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