Mallinckrodt

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Mallinckrodt FDA UDI
Generic Name: Basic endotracheal tube, single-use FDA UDI
Device Name: Oral/Nasal Tracheal Tube Cuffless, Monitoring Lumen, Murphy Eye FDA UDI
Model / Reference: 86655 FDA UDI
Description: Oral/Nasal Tracheal Tube Cuffless, Monitoring Lumen, Murphy Eye FDA UDI

Identifiers

Primary DI / UDI-DI: 20884521031972 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Basic endotracheal tube, single-use

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

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Also classified as Basic endotracheal tube, single-use.

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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

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: Covidien LP

Sources (1)

FDA UDI 3d2d6a00-6f89-4c25-be81-9a8ab6138310 35 fields · synced May 29, 2026