Catalog Number

991.8206.05

Brand Name

B Medical Systems

Version/Model Number

B401

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 10, 2020

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

192d3fd1-54fd-43f4-b6f9-f15788f1c307

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

February 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-