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Duravent 21042-05

by Andreas Fahl Medizintechnik-Vertrieb GmbH EUDAMEDGUDID

Withdrawn European Union and United States

Ref 21042-05

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number405194811000DURAVEC++PP48 Basic UDI-DIDate21 Sep 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04051948169324 UDI-DIDate29 Nov 2016ListedStatusWithdrawn

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Duravent® Pro Vario Lingo Phon 1 ICV + 1 ICF, SIZE 5 EUDAMED
Duravent GUDID
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable
Device Name
Duravec Pro PP
Model / Reference
21042-05
Primary DI / UDI-DI
04051948169324 EUDAMED
04051948038941 GUDID
Basic UDI-DI
405194811000DURAVEC++PP48
FDA Product Code
JOH, BTR, BTO
EMDN Code
R0105010101 Tracheostomic cannulas, cuffless, not reinforced, with fixed flange, and kits
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5800, 868.5730
Medical Purpose
FAHL® tracheostomy tubes are intended to stabilise the tracheostomy following laryngectomy or tracheotomy. The tracheostomy tube is designed to keep the tracheostomy open. Tracheostomy tubes with cuff can be used for mechanical ventilation, including under anaesthesia. Percutan variants are designed for additional use in percutaneous dilatation tracheostomy.
Commercial Distribution
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
04051948169324
GUDID
04051948038941
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No