Avanos

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name: AVANOS FDA UDI
Generic Name: Basic endotracheal tube, single-use FDA UDI
Device Name: MICROCUFF* Pediatric Endotracheal Tube, Oral/Nasal Magill FDA UDI
Model / Reference: 35113 FDA UDI
Description: MICROCUFF* Pediatric Endotracheal Tube, Oral/Nasal Magill FDA UDI

Identifiers

Catalog Number: 35113 FDA UDI
Primary DI / UDI-DI: 00609038351131 FDA UDI
510(k) Number: K080821 FDA UDI
FDA Product Code: BTR FDA UDI
GMDN Term: Basic endotracheal tube, single-use 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

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: Outer Diameter — 5.6 Millimeter FDA UDI

Category: Basic endotracheal tube, single-use

The AVANOS pediatric endotracheal tube (PET) is a single-use, radiopaque device designed for the insertion of an unobstructed airway into the trachea during anesthesia, resuscitation, and other medical procedures. It features a built-in pilot balloon for cuff pressure monitoring and a distal inflatable cuff to seal against the tracheal wall.

Similar devices

Also classified as Basic endotracheal tube, single-use.

Parker Flex-Tip — SALTER LABS · Class II
Mallinckrodt — Covidien LP · Class II
RediTube™ — Airlife, Inc. · Class II
Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
Endotracheal Tubes — Dynarex Corp. · Class II
ULTRAMED ENDOTRACHEAL TUBE ORAL/NASAL CUFFED Size 3 — Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) · Class IIa
Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa

Cleared under the same submission

K080821 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: Avanos Medical, Inc.

Sources (1)

FDA UDI 245999a2-ebbb-466d-a184-6294a0d589b8 37 fields · synced Jul 8, 2026