Duns Number:305682023
Device Description: Ambu WhiteSensor MRI Solid Gel
Catalog Number
7841P/5
Brand Name
Ambu WhiteSensor 7841P
Version/Model Number
7841P/5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 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
99fedc50-00ae-47b4-b3d1-1ddb81d1268a
Public Version Date
February 14, 2022
Public Version Number
3
DI Record Publish Date
June 03, 2019
Package DI Number
05707480141654
Quantity per Package
150
Contains DI Package
05707480141647
Package Discontinue Date
February 13, 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 |