SSUmini thread - SSUmini thread and packaging information - NEPHROS, INC.

Duns Number:120664557

Device Description: SSUmini thread and packaging information

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More Product Details

Catalog Number

-

Brand Name

SSUmini thread

Version/Model Number

70-0242

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

d9f6aae8-e548-4c73-8b80-2e5b3c4cd77e

Public Version Date

February 10, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10896241002203

Quantity per Package

24

Contains DI Package

00896241002206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"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