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Truwave PX3X3AN

by Edwards Lifesciences LLC

Ref PX3X3AN

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

Recall on shared 510(k) K142749; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001TDT000WX Basic UDI-DI 07460691950658UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07460691950658 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

11 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0414-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749
    • Ongoing Z-0413-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

  • 8 recalls, same reason

    • Terminated Z-1961-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1966-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1962-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1963-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1965-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1964-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1959-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1960-2021 FDA Class II initiated 26 May 2021

    There is a potential that the pressure tubing may detach from the blood sampling system

    • Terminated Z-2776-2015 FDA Class II initiated 31 Jul 2015

    Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

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
Truwave
Generic Name
Invasive-pressure external transducer, single-use
Model / Ref / Catalog
PX3X3AN
Primary DI / UDI-DI
07460691950658
Basic UDI-DI
0690103D001TDT000WX
510(k) Number
FDA Product Code
DXO
EMDN Code
Z1203020301 Invasive blood pressure monitoring instruments
GMDN Term
Invasive-pressure external transducer, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2870
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Total Volume — 3 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Invasive-pressure external transducer, single-use

Cleared under the same submission (K142749)

Show all (12)

Cleared under the same submission (K171996)

Show all (12)

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No