Identity
- Trade Name
- Truer Bougie FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medical’s Bougie is the most adaptable, cost effective bougie available in the market. Low density polyethylene frosted finish sheath reduces friction and provides proper stiffness for ease of insertion. Multiple depth marks and malleable for straight or coudé tip. FDA UDI
- Model / Reference
- 90552 FDA UDI
- Description
- Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medical’s Bougie is the most adaptable, cost effective bougie available in the market. Low density polyethylene frosted finish sheath reduces friction and provides proper stiffness for ease of insertion. Multiple depth marks and malleable for straight or coudé tip. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859290006236 FDA UDI
- FDA Product Code
- KCD FDA UDI
- GMDN Term
- Endotracheal tube introducer, 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
Yes
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: Endotracheal tube introducer, single-use
Truer Bougie by Truer Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube introducer, single-use.
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- Frova — COOK INCORPORATED · Class II
- Runnels Steerable Introducer™ #4 Oral — THROUGH THE CORDS, LLC · Class I
- Intuitive Depth Bougie™ (IDB), Coude Tip — THROUGH THE CORDS, LLC · Class I
- COOK — William Cook Europe ApS · Class II
- COOK — William Cook Europe ApS · Class II
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 5811532c-f88d-4f43-8210-5a2b1e4fd657 33 fields · synced May 30, 2026