Catalog Number

-

Brand Name

CryoStore

Version/Model Number

CS500V8

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

BK030036,BK030036

Product Code

KSR

Product Code Name

Container, Empty, For Collection & Processing Of Blood & Blood Components

Public Device Record Key

991bf74c-d92d-4b19-b464-33178bd56d44

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

January 05, 2017

Package DI Number

20816203023159

Quantity per Package

3

Contains DI Package

10816203023152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton