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ECG Cbl 6-Lead Dual-P Aha, 1M 5956474

by Draeger Medical Systems, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

6 closed

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04049098007818 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ECG Cbl 6-Lead Dual-P Aha, 1M
Generic Name
Electrocardiographic lead set, reusable
Model / Reference
5956474
Primary DI / UDI-DI
04049098007818
510(k) Number
FDA Product Code
DSA
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class II
Regulation Number
870.2900
GUDID distribution status
In Commercial Distribution

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

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

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