Identity
- Trade Name
- Shiley FDA UDI
- Generic Name
- Laryngectomy tube FDA UDI
- Device Name
- Tracheostomy Tube Cuffed with Inner Cannula FDA UDI
- Model / Reference
- 10LPC FDA UDI
- Description
- Tracheostomy Tube Cuffed with Inner Cannula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60884522007110 FDA UDI
- 510(k) Number
- K962173 FDA UDI
- FDA Product Code
- JOH FDA UDI
- GMDN Term
- Laryngectomy tube 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
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
Dimensions & Sizes
- Size
- Length — 81 Millimeter FDA UDI
Category: Laryngectomy tube
Shiley by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laryngectomy tube.
- OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
- galemed — Galemed Corp. · Class I
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class II
- OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class II
Cleared under the same submission
K962173 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI c642303e-7275-4ea2-ba8a-7fecd4f99387 37 fields · synced May 30, 2026