Adroit surgical VB-2001

GUDID 00859290006212

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.

TRUER MEDICAL, INC.

Oesophageal bougie, single-use

• Primary Device ID: 00859290006212
• NIH Device Record Key: 5103a203-49ba-4e6c-9a56-f93e7d2ece31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adroit surgical
• Version Model Number: 90545
• Catalog Number: VB-2001
• Company DUNS: 003530786
• Company Name: TRUER MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4255772713
• Email: phagen@adroitsurgical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859290006212 [Primary]
GS1	10859290006219 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	20859290006216 [Package]; Contains: 10859290006219; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• KCD: Bougie, Esophageal, Ent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2018-01-23

On-Brand Devices [Adroit surgical]

• 20859290006223: The Tactical Voir bougie (coiled tube for package convenience) is for use with an endoctracheal
• 00859290006212: The Voir Bougie (straight tube) is for use with an endoctracheal tube 6.0 mm ID and larger for a