Identity
- Trade Name
- Adroit surgical FDA UDI
- Generic Name
- Oesophageal bougie, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 90545 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- VB-2001 FDA UDI
- Primary DI / UDI-DI
- 00859290006212 FDA UDI
- FDA Product Code
- KCD FDA UDI
- GMDN Term
- Oesophageal bougie, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oesophageal bougie, single-use
Adroit surgical by Truer Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal bougie, single-use.
- Bougie Dilator — Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Class II
- TELEFLEX — TELEFLEX INCORPORATED · Class II
- Adroit Surgical — TRUER MEDICAL, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Truer Medical, Inc.
Sources (1)
- FDA UDI 5103a203-49ba-4e6c-9a56-f93e7d2ece31 36 fields · synced Jun 1, 2026