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Shiley

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Shiley FDA UDI
Generic Name
Laser-resistant endotracheal tube FDA UDI
Device Name
Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye FDA UDI
Model / Reference
86551 FDA UDI
Description
Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye FDA UDI

Identifiers

Primary DI / UDI-DI
20884521211671 FDA UDI
510(k) Number
K790575 FDA UDI
FDA Product Code
BTR FDA UDI
GMDN Term
Laser-resistant endotracheal tube 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

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
Outer Diameter — 7.5 Millimeter FDA UDI

Category: Laser-resistant endotracheal tube

Shiley by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laser-resistant endotracheal tube.

Cleared under the same submission

K790575 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 8d380b92-7f9d-4bf4-ab4b-a0e2a60e966a 36 fields · synced May 30, 2026