Catalog Number

10032

Brand Name

CryoSC-D Freezing Bag

Version/Model Number

FB-100.2

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,BK090037

Product Code

OOF

Product Code Name

Cryogenic Cord Blood Storage Container

Public Device Record Key

113c7bfe-320a-4135-8c81-fd2b77f20faa

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

January 13, 2017

Package DI Number

7640125650396

Quantity per Package

24

Contains DI Package

07640125650389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-