Catalog Number

225-028-626

Brand Name

Constavac CBC II

Version/Model Number

225-028-626

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

a15b0e73-f63c-4720-8823-a91a8e934c06

Public Version Date

October 16, 2019

Public Version Number

1

DI Record Publish Date

October 08, 2019

Package DI Number

00855168008227

Quantity per Package

6

Contains DI Package

00855168008210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack