DSU-H Quick Connect - The Nephros DSU-H is a disposable in-line water - NEPHROS, INC.

Duns Number:120664557

Device Description: The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality dri The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapurewater for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.

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More Product Details

Catalog Number

-

Brand Name

DSU-H Quick Connect

Version/Model Number

70-0285

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

K141731,K141731,K141731

Product Code Details

Product Code

NHV

Product Code Name

System, Water Purification, General Medical Use

Device Record Status

Public Device Record Key

ffb16618-a865-4fa1-b6b3-f60a14f8a933

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Additional Identifiers

Package DI Number

10896241002388

Quantity per Package

1

Contains DI Package

00896241002381

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