Identity
- Trade Name
- Montgomery® Long-Term Cannula FDA UDI
- Generic Name
- Tracheostoma button FDA UDI
- Device Name
- Size: 8 x 57 FDA UDI
- Model / Reference
- 330857 FDA UDI
- Description
- Size: 8 x 57 FDA UDI
Identifiers
- Catalog Number
- 330857 FDA UDI
- Primary DI / UDI-DI
- EBES3308570 FDA UDI
- 510(k) Number
- K802916 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Tracheostoma button FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
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
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
Category: Tracheostoma button
Montgomery® Long-Term Cannula by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K802916 also covers:
- 15 mm Adaptor — Boston Medical Products, Inc.
- 15 mm Adaptor — Boston Medical Products, Inc.
- 15 mm Adaptor — Boston Medical Products, Inc.
- 15 mm Adaptor — Boston Medical Products, Inc.
- 15 mm Adaptor — Boston Medical Products, Inc.
- 15 mm Adaptor — Boston Medical Products, Inc.
- Cannula Faceplate — Boston Medical Products, Inc.
- Cannula Faceplate — Boston Medical Products, Inc.
- Cannula Faceplate — Boston Medical Products, Inc.
- Cannula Faceplate — Boston Medical Products, Inc.
- Cannula Faceplate — Boston Medical Products, Inc.
- Cannula Faceplate — 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 4ecb0c3e-e36a-4f11-bd24-853e1cec1aa4 38 fields · synced Jun 9, 2026