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TriVantage™

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
TriVantage™ FDA UDI
Generic Name
Basic endotracheal tube, single-use FDA UDI
Device Name
EMG TUBE 8229736 3PK NIM TRIVANTAGE 6MM FDA UDI
Model / Reference
8229736 FDA UDI
Description
EMG TUBE 8229736 3PK NIM TRIVANTAGE 6MM FDA UDI

Identifiers

Primary DI / UDI-DI
20643169060832 FDA UDI
510(k) Number
K112686 FDA UDI
FDA Product Code
ETN FDA UDI
GMDN Term
Basic endotracheal tube, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1820 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 6.0 Millimeter FDA UDI
Outer Diameter — 8.2 Millimeter FDA UDI

TriVantage™ by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K112686 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI b6bf124a-1a87-408a-b6e1-5834ced63a65 37 fields · synced May 30, 2026