Identity
- Trade Name
- Shiley FDA UDI
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
- Device Name
- Adult Flexible Tracheostomy Tube Cuffless Reusable Inner Cannula FDA UDI
- Model / Reference
- 8UN85R FDA UDI
- Description
- Adult Flexible Tracheostomy Tube Cuffless Reusable Inner Cannula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521205529 FDA UDI
- 510(k) Number
- K150844 FDA UDI
- FDA Product Code
- JOH FDA UDI
- GMDN Term
- Tracheostomy tube, non-reinforced, non-customized, single-use 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 — 79 Millimeter FDA UDIAngle — 90 degree FDA UDIOuter Diameter — 12.2 Millimeter FDA UDI
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Shiley by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
- TRACOE mini — Tracoe medical GmbH · Class II
- PRIMEDISILK® Silikonkanüle, Gr.10 Länge 62 mm ohne Konnektor — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Tracheal Stent with Mesh and Posts — HOOD, E BENSON LABORATORIES INC · Class II
- Trachealkanüle PRIMEDISTOM®, Gr.10, L = 85 mm — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Trachealkanüle Ultrasoft Suction Gr.8 — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Silber Innenkanüle mit Adaptionsring für rundes Kastenventil gesiebt — Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH · Class IIb
- TRACOE silcosoft — Tracoe medical GmbH · Class II
- Trachealkanüle PRIMEDISTOM®, Gr.5, gesiebt, überlang, L = 92 mm — Primed Halberstadt Medizintechnik GmbH · Class IIb
Cleared under the same submission
K150844 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI b640a84a-221e-432c-b1b4-f4e85b8c1df5 36 fields · synced Jun 8, 2026