Catalog Number

-

Brand Name

Ambu WhiteSensor

Version/Model Number

4500M-H

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"

Yes

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

-

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

adbb7926-a904-42e1-9063-e97d5bd34dae

Public Version Date

August 28, 2020

Public Version Number

1

DI Record Publish Date

August 20, 2020

Package DI Number

18906035282918

Quantity per Package

5

Contains DI Package

08906035282911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-