Duns Number:305682023
Device Description: Ambu WhiteSensor ST Monitoring MRI Wet Gel
Catalog Number
4500M/3
Brand Name
Ambu WhiteSensor 4500M
Version/Model Number
4500M/3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 06, 2021
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
358893c4-1963-401b-bea9-14f7384612cf
Public Version Date
May 06, 2021
Public Version Number
3
DI Record Publish Date
June 03, 2019
Package DI Number
05707480141531
Quantity per Package
200
Contains DI Package
05707480141524
Package Discontinue Date
May 06, 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 |