Duns Number:305682023
Device Description: Ambu WhiteSensor, WS 4 /pack
Catalog Number
WS-00-S/4
Brand Name
Ambu WhiteSensor WSECG Electrodes
Version/Model Number
WS-00-S/4
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 12, 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
30d145b5-24f7-4ab0-b7c3-012f20c912bf
Public Version Date
June 13, 2022
Public Version Number
4
DI Record Publish Date
September 29, 2016
Package DI Number
05707480108343
Quantity per Package
10
Contains DI Package
05707480108336
Package Discontinue Date
June 12, 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 |