Catalog Number

4C2243

Brand Name

Fenwal Plasma Transfer Sets with Two Spikes

Version/Model Number

4C2243

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

48d2877a-d72a-4493-94df-828f591ca853

Public Version Date

June 29, 2018

Public Version Number

1

DI Record Publish Date

May 29, 2018

Package DI Number

24052682004166

Quantity per Package

48

Contains DI Package

14052682004169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box