Catalog Number

225-028-085

Brand Name

ConstaVac CBC II

Version/Model Number

225-028-085

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

K970714,K970714

Product Code

CAC

Product Code Name

Apparatus, Autotransfusion

Public Device Record Key

8c1316b0-86c1-4e7a-b18a-d837aa23372b

Public Version Date

May 10, 2019

Public Version Number

1

DI Record Publish Date

May 02, 2019

Package DI Number

00855168008241

Quantity per Package

6

Contains DI Package

00855168008234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack