Duns Number:305682023
Device Description: Ambu WhiteSensor WS/RT
Catalog Number
WS-00-S/RT/50
Brand Name
Ambu WhiteSensor WSECG Electrodes
Version/Model Number
WS-00-S/RT/50
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 05, 2022
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
363cd024-cc1d-4d05-9934-051faf3d1b61
Public Version Date
June 06, 2022
Public Version Number
4
DI Record Publish Date
September 25, 2016
Package DI Number
05707480129065
Quantity per Package
12
Contains DI Package
05707480129058
Package Discontinue Date
June 05, 2022
Package Status
Not 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 |