Identity
- Trade Name
- Standard Tracheal T-Tube FDA UDI
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
- Device Name
- Montgomery Tracheal T-Tube FDA UDI
- Model / Reference
- ST-510-S FDA UDI
- Description
- Montgomery Tracheal T-Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815347020174 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- Not 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
Dry Heat Sterilization FDA UDI
MR Safe FDA UDI
Standard Tracheal T-Tube by Hood, E Benson Laboratories Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hood, E Benson Laboratories Inc
Sources (1)
- FDA UDI d59010f3-41e1-4a63-906a-90ca77be408a 34 fields · synced May 30, 2026