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Na 70ANM5

by Edwards Lifesciences LLC

Ref 70ANM5

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001CBL000ML Basic UDI-DI 00690103002737UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103002737 UDI-DI Date3 Sep 2016ListedStatusListed 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

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

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  • Withdrawn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

Generic Name
Electrical-only medical device connection cable, reusable
Device Name
Reusable cables
Model / Ref / Catalog
70ANM5
Primary DI / UDI-DI
00690103002737
Basic UDI-DI
0690103D001CBL000ML
Direct Marketing DI
00690103002737
510(k) Number
FDA Product Code
DXG
EMDN Code
Z12030299 Vital signs monitoring instruments - other
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1435
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 8 Feet

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 (K043103)

Show all (12)

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No