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Na 64EKHH

by Edwards Lifesciences LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103002478 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-0942-2012 FDA Unclassified (pre-2012) initiated 12 Sep 2008

    Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate Injectate Cardiac Output (ICO) measurements.

    • Terminated Z-0262-2008 FDA Unclassified (pre-2012) initiated 17 May 2007

    MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25mmHg. Since the MAP is used in calculations of various patient parameters such as SVR,

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
64EKHH
Primary DI / UDI-DI
00690103002478
510(k) Number
FDA Product Code
DXG
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class II
Regulation Number
870.1435
GUDID distribution status
In Commercial Distribution
Size
Length — 8 Feet

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K043103)

Show all (12)

Other devices from Edwards Lifesciences LLC

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Properties

  • Prescription Use
  • Expiration Date

Other properties (12)

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