Duns Number:003530786
Device Description: The Voir Bougie (straight tube) is for use with an endoctracheal tube 6.0 mm ID and larger The Voir Bougie (straight tube) 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 Voir Bougie 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-2001
Brand Name
Adroit surgical
Version/Model Number
90545
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)
-
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
5103a203-49ba-4e6c-9a56-f93e7d2ece31
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
January 23, 2018
Package DI Number
10859290006219
Quantity per Package
10
Contains DI Package
00859290006212
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 |