Catalog Number

WS-00-S/5

Brand Name

Ambu WhiteSensor WSECG Electrodes

Version/Model Number

WS-00-S/5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 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"

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

65f78343-3de1-4600-ad68-30e2e98bee40

Public Version Date

September 10, 2020

Public Version Number

3

DI Record Publish Date

September 29, 2016

Package DI Number

05707480108398

Quantity per Package

10

Contains DI Package

05707480108381

Package Discontinue Date

September 10, 2020

Package Status

Not in Commercial Distribution

Package Type

-