Catalog Number

4C2240

Brand Name

Fenwal Plasma Transfer Sets with Spike and Male Luer Adapter

Version/Model Number

4C2240

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KSB

Product Code Name

Set, Transfer (Blood/Plasma)

Public Device Record Key

28e0c6e4-25da-4af3-86de-b7c0e8c13dd3

Public Version Date

April 26, 2018

Public Version Number

1

DI Record Publish Date

March 26, 2018

Package DI Number

24052682004265

Quantity per Package

48

Contains DI Package

14052682004268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box