Duns Number:305682023
Device Description: Ambu WhiteSensor ST Monitoring MRI Wet Gel
Catalog Number
4500M/5
Brand Name
Ambu WhiteSensor 4500M
Version/Model Number
4500M/5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
59fb65af-4470-4120-8877-830c1e13b716
Public Version Date
June 11, 2019
Public Version Number
1
DI Record Publish Date
June 03, 2019
Package DI Number
05707480141500
Quantity per Package
6
Contains DI Package
05707480141494
Package Discontinue Date
-
Package Status
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 |