Catalog Number

225-028-085S1

Brand Name

Constavac CBC II

Version/Model Number

225-028-085S1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 18, 2022

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

1700e920-c337-4bfc-84d2-1e9d9e319679

Public Version Date

April 19, 2022

Public Version Number

2

DI Record Publish Date

April 25, 2019

Package DI Number

00855168008340

Quantity per Package

6

Contains DI Package

00855168008333

Package Discontinue Date

April 18, 2022

Package Status

Not in Commercial Distribution

Package Type

Pack