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Guedel Airway Length 11 cm Size 5 038-91-945U

by Flexicare Medical Limited

Ref 038-91-945U

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Overview

This Guedel Airway Length 11 cm Size 5 is a single-use oropharyngeal airway, designed to facilitate gas exchange and suctioning during medical procedures. Its curved metal or plastic tube prevents the tongue from obstructing airflow, making it an effective tool for patients who require assisted ventilation.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788771135 Basic UDI-DI 05055788771135UDI-DIDate15 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788771135 UDI-DI Date28 Jan 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Guedel Airway Length 11 cm Size 5
Generic Name
Oropharyngeal airway, single-use
Device Name
Oropharyngeal Airways
Model / Reference
038-91-945U
Primary DI / UDI-DI
05055788771135
Basic UDI-DI
B-05055788771135
FDA Product Code
CAE
EMDN Code
R010102 Guedel airway tubes
GMDN Term
Oropharyngeal airway, single-use
Device Class
Class I
Regulation Number
868.5110
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Oropharyngeal airway, single-use

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No