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Oxylog 3000plus 5704833

by Dragerwerk AG EUDAMEDGUDID

Withdrawn European Union and United States

Ref 5704833Model 304015FK19Z000

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number040486751304015FK19Z000XW Basic UDI-DIDate27 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04048675249214 UDI-DIDate24 Oct 2015ListedStatusWithdrawn

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: none listed in EUDAMED

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2018-2023 FDA Class I initiated 12 Jun 2023

    Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.

  • 2 recalls, same reason

    • Terminated Z-0691-2016 FDA Class I initiated 22 Dec 2015
    • Terminated Z-0692-2016 FDA Class I initiated 22 Dec 2015

    Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.

    • Terminated Z-1440-2014 FDA Class I initiated 5 Mar 2014 via K103625, on the same 510(k)

    The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID

Trade Name
Oxylog 3000 plus EUDAMED
Oxylog 3000plus GUDID
Generic Name
Transport electric ventilator
Model / Reference
5704833, 304015FK19Z000
Primary DI / UDI-DI
04048675249214
Basic UDI-DI
040486751304015FK19Z000XW
Direct Marketing DI
04048675249221
510(k) Number
FDA Product Code
CBK
EMDN Code
Z12030104 Portable pulmonary ventilators
GMDN Term
Transport electric ventilator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5895
Market of Registration
Germany
Commercial Distribution
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Dragerwerk AG

See all devices from Dragerwerk AG →

Properties

  • CMR Substance
  • Administering Medicine
  • Measuring Function
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No