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Mallinckrodt

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Mallinckrodt FDA UDI
Generic Name
Oesophageal-obturating/tracheal airway, single-use FDA UDI
Device Name
Esophageal Tracheal Airway with X-Ray Line,Double Lumen FDA UDI
Model / Reference
5-18537 FDA UDI
Description
Esophageal Tracheal Airway with X-Ray Line,Double Lumen FDA UDI

Identifiers

Primary DI / UDI-DI
10884521103627 FDA UDI
510(k) Number
K875226 FDA UDI
FDA Product Code
CAO FDA UDI
GMDN Term
Oesophageal-obturating/tracheal airway, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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
Catheter Gauge — 37 French FDA UDI

Category: Oesophageal-obturating/tracheal airway, single-use

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

Similar devices

Also classified as Oesophageal-obturating/tracheal airway, single-use.

Cleared under the same submission

K875226 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 1cf3207f-d5df-4be4-a097-baf912fd55e5 37 fields · synced May 30, 2026