Catalog Number

5050-00-S/5

Brand Name

Ambu WhiteSensor 5050

Version/Model Number

5050-00-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

80f9afc1-2d47-463e-9f5d-d801f88a1227

Public Version Date

September 10, 2020

Public Version Number

2

DI Record Publish Date

June 21, 2019

Package DI Number

05707480141258

Quantity per Package

150

Contains DI Package

05707480141241

Package Discontinue Date

September 10, 2020

Package Status

Not in Commercial Distribution

Package Type

-