Catalog Number

4085

Brand Name

Overwrap Bag

Version/Model Number

Overwrap Bag

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

-

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,BK090037

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

950812b0-6339-41a0-845c-359224c7f392

Public Version Date

March 23, 2022

Public Version Number

4

DI Record Publish Date

September 18, 2016

Package DI Number

07640125650525

Quantity per Package

100

Contains DI Package

07640125650518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-