Duns Number:305682023
Device Description: Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For short-term monitoring Packing: 60 pouch/300 inner box/ 3000 carton
Catalog Number
4535M
Brand Name
Ambu WhiteSensor 4535MECG Electrodes
Version/Model Number
4535M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 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
d62832dc-7a92-4f2a-bc87-c03cd9fe9089
Public Version Date
February 01, 2021
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
05060038512857
Quantity per Package
5
Contains DI Package
05060038512864
Package Discontinue Date
January 31, 21
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 |