Duns Number:305682023
Device Description: Ambu WhiteSensor 12 Lead ECG 4 mm MRI Wet Gel
Catalog Number
4540
Brand Name
Ambu WhiteSensor 4540ECG Electrodes
Version/Model Number
4540
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2020
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
cfb845b5-cf0d-4115-a177-e5ef6cd16a9a
Public Version Date
September 10, 2020
Public Version Number
3
DI Record Publish Date
September 26, 2016
Package DI Number
05707480131808
Quantity per Package
8
Contains DI Package
05707480131815
Package Discontinue Date
September 10, 2020
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 |