Duns Number:392994778
Device Description: bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø2.5mm - 3.5mm
Catalog Number
00557603
Brand Name
VYGON
Version/Model Number
5576.03
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
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
BSR
Product Code Name
STYLET, TRACHEAL TUBE
Public Device Record Key
2102b2ac-6fde-40bf-a776-9ef6ed1a3d25
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 2021
Package DI Number
33660812109513
Quantity per Package
10
Contains DI Package
03660812109512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |