Identity
- Trade Name
- Plug/Ring Set FDA UDI
- Generic Name
- Tracheostomy tube decannulation cap FDA UDI
- Device Name
- Size: 8/9 mm FDA UDI
- Model / Reference
- 321086 FDA UDI
- Description
- Size: 8/9 mm FDA UDI
Identifiers
- Catalog Number
- 321086 FDA UDI
- Primary DI / UDI-DI
- 14063107100236 FDA UDI
- 510(k) Number
- K843936 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Tracheostomy tube decannulation cap 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
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 decannulation cap
Plug/Ring Set by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube decannulation cap.
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- PILLING — TELEFLEX INCORPORATED · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- TRACOE modular — Tracoe medical GmbH · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- PILLING — TELEFLEX INCORPORATED · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 932f5177-f249-4bbf-9e13-7356ee48e59f 38 fields · synced Jun 9, 2026