Identity
- Trade Name
- Montgomery® Safe-T-Tube™ FDA UDI
- Generic Name
- Trachea prosthesis FDA UDI
- Device Name
- Tracheal T-Tube, Thoracic, 10 mm, Clear FDA UDI
- Model / Reference
- 560010 FDA UDI
- Description
- Tracheal T-Tube, Thoracic, 10 mm, Clear FDA UDI
Identifiers
- Catalog Number
- 560010 FDA UDI
- Primary DI / UDI-DI
- 14063107103305 FDA UDI
- 510(k) Number
- K843936 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Trachea prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Trachea prosthesis
Montgomery® Safe-T-Tube™ by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trachea prosthesis.
- WALLSTENT™ RP Endoprosthesis — Boston Scientific · Class II
- WALLSTENT® Endoprosthesis — Boston Scientific · Class II
- WALLGRAFT® — Boston Scientific · Class II
- WALLGRAFT® — Boston Scientific · Class II
- WALLSTENT™ RP Endoprosthesis — Boston Scientific · Class II
- WALLSTENT® Endoprosthesis — Boston Scientific · Class II
- WALLGRAFT® — Boston Scientific · Class II
- WALLSTENT™ RP Endoprosthesis — Boston Scientific · Class II
Cleared under the same submission
K843936 also covers:
- 15 mm Adaptor — Boston Medical Products, Inc.
- 15 mm Adaptor — Boston Medical Products, Inc.
- 15 mm Adaptor — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
- Montgomery® Safe-T-Tube™ — Boston Medical Products, Inc.
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
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 5eb0bdbe-169b-42b5-9f42-4e10cb9a165e 38 fields · synced Jun 9, 2026