Catalog Number

991.8306.**

Brand Name

B Medical Systems

Version/Model Number

B51

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Public Device Record Key

bb1548f0-d5c3-43e5-a6d4-943a094f9084

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-