Duns Number:305682023
Device Description: Ambu WhiteSensor LT Monitoring MRI Wet Gel
Catalog Number
4440
Brand Name
Ambu WhiteSensor 4440ECG Electrodes
Version/Model Number
4440
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 07, 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
2c9f156a-ae88-4b4e-affd-18517366793b
Public Version Date
March 08, 2021
Public Version Number
4
DI Record Publish Date
November 30, 2016
Package DI Number
05707480133185
Quantity per Package
10
Contains DI Package
05707480133178
Package Discontinue Date
March 07, 2021
Package Status
Not in Commercial Distribution
Package Type
Case
| 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 |