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ECG Cbl MonoLead 4 AHA/US 3.7m MS20475

by Draeger Medical Systems, Inc.

Ref MS20475Model 1070256K19Z200

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

6 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0404867521070256K19Z200SG Basic UDI-DI 04049098003742UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049098003742 UDI-DI Date24 Oct 2015ListedStatusListed 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

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
EKG Kbl MonoLead 4 AHA/US 3,7m EUDAMED
ECG Cbl MonoLead 4 AHA/US 3.7m GUDID
Generic Name
Electrocardiographic lead set, reusable
Model / Reference
MS20475, 1070256K19Z200
Primary DI / UDI-DI
04049098003742
Basic UDI-DI
0404867521070256K19Z200SG
510(k) Number
FDA Product Code
DSA
EMDN Code
Z12050380 Electrocardiographs - hardware accessories
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
EU 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: Electrocardiographic lead set, 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

  • Manufacturing Date

Other properties (23)

  • 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
  • Serial Number: No
  • Expiration Date: No