Duns Number:305682023
Device Description: WhiteSensor Short Monitoring Solid Gel foam round
Catalog Number
4300
Brand Name
Ambu WhiteSensor 4300ECG Electrodes
Version/Model Number
4300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 21, 2022
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
8bd3f6bb-954c-4253-91fd-4fe13b1e2479
Public Version Date
October 08, 2020
Public Version Number
3
DI Record Publish Date
September 26, 2016
Package DI Number
05707480132218
Quantity per Package
8
Contains DI Package
05707480132225
Package Discontinue Date
December 21, 2022
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |