Duns Number:305682023
Device Description: Ambu aScope 3 - Video Bronchioscope Single-Use, Flexible and Sterile. Insertion cord dia 5 Ambu aScope 3 - Video Bronchioscope Single-Use, Flexible and Sterile. Insertion cord dia 5.0 mm, channel width of 2.2 mm. Bending angle of 150°/130° Min. ordering 5 pcs. = 1 box.
Catalog Number
403001000
Brand Name
aScope™ 3 Regular 5.0/2.2Flexible Videoscope - Single Use
Version/Model Number
403001000
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"
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
EOQ
Product Code Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
183f5204-3c39-481c-86a8-b0f36e4a2b53
Public Version Date
July 16, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
05707480122011
Quantity per Package
4
Contains DI Package
05707480122004
Package Discontinue Date
-
Package Status
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 |