Duns Number:305682023
Device Description: Ambu WhiteSensor LT Monitoring MRI Wet Gel
Catalog Number
4440/3
Brand Name
Ambu WhiteSensor 4440
Version/Model Number
4440/3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2020
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
f7f4dd0a-d79d-48ee-8a28-ac6b7f3424d8
Public Version Date
September 10, 2020
Public Version Number
2
DI Record Publish Date
June 03, 2019
Package DI Number
05707480141777
Quantity per Package
200
Contains DI Package
05707480141760
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 |