Duns Number:003530786
Device Description: The Tactical Voir bougie (coiled tube for package convenience) is for use with an endoctra The Tactical Voir bougie (coiled tube for package convenience) is for use with an endoctracheal tube 6.0 mm ID and larger for adult patients to guide the direction of the endotracheal tube (ETT) between the vocal cords. The Tactical Voir Bougije has clearly marked colored bands (patent pending) that allow the user to quickly insert the Bougie the correct distance into the trachea. The product has been designed for use by EMS and healthcare practitioners trained and experienced in airway management techniques.
Catalog Number
VB-3001
Brand Name
Adroit Surgical
Version/Model Number
90546
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCD
Product Code Name
Bougie, Esophageal, Ent
Public Device Record Key
a22b1bf5-f2cc-4c68-83ed-00bc0bee9102
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
January 23, 2018
Package DI Number
20859290006223
Quantity per Package
10
Contains DI Package
10859290006226
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |