Duns Number:305682023
Device Description: Ambu White Sensor 4831Q Electrode with Bio-Tack sticky gel and foam backing. Center snap a Ambu White Sensor 4831Q Electrode with Bio-Tack sticky gel and foam backing. Center snap and PVC free For short-term monitoring adult and pediatric. Packing: 60 pouch/300 inner box/ 3000 carton
Catalog Number
4831Q
Brand Name
Ambu WhiteSensor 4831QECG Electrodes
Version/Model Number
4831Q
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 04, 2021
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
8ca5432d-fd26-496a-9efa-de4cb31fd611
Public Version Date
December 06, 2021
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
05707480129768
Quantity per Package
10
Contains DI Package
05060038515223
Package Discontinue Date
December 04, 2021
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 |