Identity
- Trade Name
- Mallinckrodt FDA UDI
- Generic Name
- Oesophageal-obturating/tracheal airway, single-use FDA UDI
- Device Name
- Esophageal Tracheal Airway Trainer,Esophageal Tracheal Airway; 20 mL Syringe; 140 mL Syringe; Suction Catheter; Elbow; Not For Human Use Mannequin Demonstrations only. Manufactured under license of Frass and Frenzer. FDA UDI
- Model / Reference
- 5-18141 FDA UDI
- Description
- Esophageal Tracheal Airway Trainer,Esophageal Tracheal Airway; 20 mL Syringe; 140 mL Syringe; Suction Catheter; Elbow; Not For Human Use Mannequin Demonstrations only. Manufactured under license of Frass and Frenzer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521103641 FDA UDI
- 510(k) Number
- K875226 FDA UDI
- FDA Product Code
- CAO FDA UDI
- GMDN Term
- Oesophageal-obturating/tracheal airway, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5650 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 41 French FDA UDI
Category: Oesophageal-obturating/tracheal airway, single-use
This esophageal tracheal airway trainer is designed for medical professionals to provide critical care during emergencies. It features a unique two-lumen design with an oropharyngeal balloon seal and distal cuff to maintain airway patency while securing the oesophagus or trachea.
Similar devices
Also classified as Oesophageal-obturating/tracheal airway, single-use.
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- Berman Oral Airway — WESTMED, INC. · Class I
- Berman Oral Airway — WESTMED, INC. · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Procure — Twin Med, LLC · Class I
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 4e1b8f9f-0ad1-4d0e-9905-f66e43f32652 37 fields · synced Jul 24, 2026