Identity
- Trade Name
- Runnels Steerable Introducer™ #2.5 Oral/Nasal FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 12 Fr, latex free, single use, sterile, fits 4.5 and larger ID tubes. FDA UDI
- Model / Reference
- 001091 FDA UDI
- Description
- Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 12 Fr, latex free, single use, sterile, fits 4.5 and larger ID tubes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850059297063 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
Runnels Steerable Introducer™ #2.5 Oral/Nasal 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 e2d9b423-491f-45ba-bb46-c9a587b661b1 34 fields · synced May 30, 2026