Catalog Number

7031

Brand Name

Traceability Labels for Bioarchive

Version/Model Number

Traceability Labels for Bioarchive

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

BK090037

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

87322515-818d-485a-bedd-25ce71b498c7

Public Version Date

March 23, 2022

Public Version Number

4

DI Record Publish Date

September 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-