Duns Number:305682023
Device Description: Ambu WhiteSensor ST Monitoring Wet Gel
Catalog Number
4535M/5
Brand Name
Ambu WhiteSensor 4535M
Version/Model Number
4535M/5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2020
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
d58cd57e-62d3-4f5e-8537-6e33ae6add22
Public Version Date
September 10, 2020
Public Version Number
2
DI Record Publish Date
June 03, 2019
Package DI Number
05707480141586
Quantity per Package
6
Contains DI Package
05707480141579
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 |