Catalog Number

WS-00-S/RT/5

Brand Name

Ambu WhiteSensor WS

Version/Model Number

WS-00-S/RT/5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 06, 2021

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

d8a8f76d-0c65-4942-ae50-b24ddb0c551d

Public Version Date

June 07, 2021

Public Version Number

3

DI Record Publish Date

June 03, 2019

Package DI Number

05707480141821

Quantity per Package

6

Contains DI Package

05707480141814

Package Discontinue Date

June 06, 2021

Package Status

Not in Commercial Distribution

Package Type

-