Catalog Number

225-416-000

Brand Name

ConstaVac CBC II

Version/Model Number

225-416-000

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

2f6a1466-5166-4d0b-ad99-1d610530493c

Public Version Date

May 10, 2019

Public Version Number

1

DI Record Publish Date

May 02, 2019

Package DI Number

00855168008043

Quantity per Package

6

Contains DI Package

00855168008036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack