Identity
- Trade Name
- Intuitive Depth Bougie™ (IDB), Coude Tip FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- Bougie with intuitive colored depth system, 70 CM, 15 Fr, not made with natural rubber latex, single use, sterile, fits 6.0 and larger ID tubes FDA UDI
- Model / Reference
- 000118 FDA UDI
- Description
- Bougie with intuitive colored depth system, 70 CM, 15 Fr, not made with natural rubber latex, single use, sterile, fits 6.0 and larger ID tubes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860581002608 FDA UDI
- FDA Product Code
- BSR FDA UDI
- GMDN Term
- Endotracheal tube introducer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5790 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Intuitive Depth Bougie™ (IDB), Coude Tip by Through The Cords, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube introducer, single-use.
- Bougie / Introducer OD 5.0mm (15Ch) 700mm — FLEXICARE MEDICAL LIMITED · Class I
- Frova — COOK INCORPORATED · Class I
- Frova — COOK INCORPORATED · Class II
- Truer Bougie — TRUER MEDICAL, INC. · Class I
- COOK — William Cook Europe ApS · Class II
- COOK — William Cook Europe ApS · Class II
- USB™ UNIVERSAL STYLET BOUGIE 15FR OD 5.0 MM — Intersurgical Incorporated · Class I
- Bougie / Introducer OD 3.3mm (10Ch) 700mm — FLEXICARE MEDICAL LIMITED · 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
- Through The Cords, Llc
Sources (1)
- FDA UDI 6f5c579d-a798-4044-b2c0-81d64cc0a865 34 fields · synced Jun 8, 2026