Duns Number:305682023
Device Description: Ambu WhiteSensor ST Monitoring Wet Gel
Catalog Number
4500M-H/10
Brand Name
Ambu WhiteSensor 4500M-HECG Electrodes
Version/Model Number
4500M-H/10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 12, 2022
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
099cc108-444d-485d-8c0b-74731aad8ff2
Public Version Date
June 13, 2022
Public Version Number
3
DI Record Publish Date
October 02, 2018
Package DI Number
05707480137978
Quantity per Package
30
Contains DI Package
05707480137961
Package Discontinue Date
June 12, 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 |