Duns Number:305682023
Device Description: Ambu aView, new updated version. Reusable, portable monitor with touch-screen Compatible w Ambu aView, new updated version. Reusable, portable monitor with touch-screen Compatible with all aScope4 versions, aScope3 versions and VivaSight-DL and SL. With Video-out function and live zoom for a more large and detailed view.
Catalog Number
405002000
Brand Name
aView™ Monitor
Version/Model Number
405002000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
-
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
EOQ
Product Code Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
c4d15dfc-6ccd-46c7-b7a2-9cedaf15ec47
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |