Catalog Number

0225-426-000W

Brand Name

NA

Version/Model Number

0225426000W

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

675e6724-6f23-44a4-97d7-7d12deb3dd34

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

37613327051279

Quantity per Package

6

Contains DI Package

07613327051278

Package Discontinue Date

December 31, 2018

Package Status

Not in Commercial Distribution

Package Type

pack