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Flowmeter, Digital Flexmount, 4 Cylinder 26400-4C

by Accutron

Ref 26400-4CModel Digital Flowmeter

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

4 closed

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813830025132 Basic UDI-DI 00813830025132UDI-DIDate24 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813830025132 UDI-DI Date19 Apr 2023ListedStatusListed 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.

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0017-2013 FDA Class I initiated 29 Apr 2012
    • Terminated Z-0018-2013 FDA Class I initiated 29 Apr 2012
    • Terminated Z-0020-2013 FDA Class I initiated 29 Apr 2012
    • Terminated Z-0019-2013 FDA Class I initiated 29 Apr 2012

    Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.

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  • Withdrawn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
Accutron Inc. EUDAMED
Flowmeter, Digital Flexmount, 4 Cylinder GUDID
Generic Name
Oxygen/air/nitrous oxide breathing gas mixer
Model / Ref / Catalog
26400-4C, Digital Flowmeter
Primary DI / UDI-DI
00813830025132
Basic UDI-DI
B-00813830025132
510(k) Number
FDA Product Code
BSZ
EMDN Code
Z1203010101 Anaesthesia devices
GMDN Term
Oxygen/air/nitrous oxide breathing gas mixer
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5160
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K052335)

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Properties

  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

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