Identity
- Trade Name
- Cannula Faceplate FDA UDI
- Generic Name
- Tracheostomy tube dressing FDA UDI
- Device Name
- Size: 10 FDA UDI
- Model / Reference
- 311003 FDA UDI
- Description
- Size: 10 FDA UDI
Identifiers
- Catalog Number
- 311003 FDA UDI
- Primary DI / UDI-DI
- 14063107100113 FDA UDI
- 510(k) Number
- K802916 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Tracheostomy tube dressing 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
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
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: Tracheostomy tube dressing
Cannula Faceplate by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube dressing.
- TRACOE care — Tracoe medical GmbH · Class I
- Resp-O2 Tracheostomy Gauze Sponges, Sterile — Dynarex Corp. · Class I
- DermaFoam Tracheostomy — DERMARITE INDUSTRIES LLC · Class I
- TRACOE care — Tracoe medical GmbH · Class I
- PolyMem — Ferris Mfg. Corp. · Class I
- TRACOE care — Tracoe medical GmbH · Class I
- TRACOE care — Tracoe medical GmbH · Class I
- TRACOE care — Tracoe medical GmbH · Class I
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.
- Montgomery® Long-Term Cannula — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 8f949c9d-8e0f-402d-b680-1c0cab6f0ad3 38 fields · synced Jun 9, 2026