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Hemo Pod Adapter, Argon 3375941

by Draeger Medical Systems, Inc. EUDAMEDGUDID

Active European Union

Ref 3375941Model 1070276K19Z340

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0404867521070276K19Z340UF Basic UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049098054232 UDI-DIDate2 Nov 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

6 recalls · FDA

    • Terminated Z-0281-2012 FDA Unclassified (pre-2012) initiated 31 Oct 2011 on shared 510(k) K070566

    Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements.

  • 2 recalls, same reason

    • Terminated Z-3047-2011 FDA Unclassified (pre-2012) initiated 29 Jul 2011 on shared 510(k) K070566
    • Terminated Z-3048-2011 FDA Unclassified (pre-2012) initiated 29 Jul 2011 on shared 510(k) K070566

    Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.

  • 2 recalls, same reason

    • Terminated Z-2283-2010 FDA Unclassified (pre-2012) initiated 4 Jun 2010 on shared 510(k) K070566
    • Terminated Z-2284-2010 FDA Unclassified (pre-2012) initiated 4 Jun 2010 on shared 510(k) K070566

    Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.

    • Terminated Z-0582-2010 FDA Unclassified (pre-2012) initiated 9 Nov 2009 on shared 510(k) K070566

    monitor is rebooting/resetting

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID

Trade Name
Hemo Pod-Adapter, Merit EUDAMED
Hemo Pod Adapter, Argon GUDID
Generic Name
Electrical-only medical device connection cable, reusable
Model / Reference
3375941, 1070276K19Z340
Primary DI / UDI-DI
04049098054232
Basic UDI-DI
0404867521070276K19Z340UF
510(k) Number
FDA Product Code
DSA
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K070566)

Show all (12)

Other devices from Draeger Medical Systems, Inc.

See all devices from Draeger Medical Systems, Inc. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • 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
  • Administering Medicine: No
  • Measuring Function: 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