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Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W HX22V-C0W

by Spectrum Medical Limited

Ref HX22V-C0WModel Quantum PureFlow Cardioplegia Heat Exchanger W

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

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
United StatesGUDID listing GUDID Number18051160302274 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8051160300013QS Basic UDI-DI 18051160302274UDI-DIDate19 Jun 2025RegisteredStatusActive

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 · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3327-2026 FDA Class II initiated 17 Jul 2026
    • Ongoing Z-3328-2026 FDA Class II initiated 17 Jul 2026

    Due to blood-to-glycol leak in the heat exchanger.

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  • Withdrawn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
Quantum PureFlow EUDAMED
Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W GUDID
Generic Name
Cardiopulmonary bypass system heat exchanger, single-use
Device Name
Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 W
Model / Reference
HX22V-C0W, Quantum PureFlow Cardioplegia Heat Exchanger W
Primary DI / UDI-DI
18051160302274
Basic UDI-DI
8051160300013QS
510(k) Number
FDA Product Code
DTR
EMDN Code
C030199 Extracorporeal and assisted circulation devices - other
GMDN Term
Cardiopulmonary bypass system heat exchanger, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4240
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K220110)

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Other devices from Spectrum Medical Limited

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Properties

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

Other properties (18)

  • 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