Teleflex

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: TELEFLEX FDA UDI
Generic Name: Cuff-suction endotracheal tube FDA UDI
Device Name: TFX ISIS SUBGLOTTIC SEC. ETT, 9.0 FDA UDI
Model / Reference: IPN044815 FDA UDI
Description: TFX ISIS SUBGLOTTIC SEC. ETT, 9.0 FDA UDI

Identifiers

Catalog Number: 5-13018 FDA UDI
Primary DI / UDI-DI: 04026704588381 FDA UDI
510(k) Number: K091761 FDA UDI
FDA Product Code: BTR FDA UDI
GMDN Term: Cuff-suction 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 15 Millimeter FDA UDI

Category: Cuff-suction endotracheal tube

Teleflex by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K091761 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: Teleflex Incorporated

Sources (1)

FDA UDI c7c31e6a-8647-44e1-a956-27770b916f51 38 fields · synced May 30, 2026