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Mps 5001104

by Quest Medical Inc

Ref 5001104

Mps 5001104 is a cardioplegia solution administration kit (EU MDD Class IIa; FDA Class II; FDA product code DTR, Heat-Exchanger, Cardiopulmonary Bypass) made by Quest Medical Inc, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-00634624501140), cleared under FDA 510(k) K953838 on 6 Mar 1996 and listed in FDA GUDID since 16 Sep 2015 (UDI-DI 00634624501140), active as of 25 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K953838

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00634624501140 Basic UDI-DI 00634624501140UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00634624501140 UDI-DI Date16 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK953838 Date6 Mar 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00634624501140 registered 16 Sep 2026 Active
  • FDA 510(k) K953838 decided 6 Mar 1996 Active
  • FDA GUDID UDI-DI 00634624501140 listed 16 Sep 2015 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0361-2016 FDA Class II initiated 28 Oct 2015

    The products have been found to intermittently exhibit a seal failure during use.

    • Terminated Z-1924-2011 FDA Unclassified (pre-2012) initiated 29 Jul 2010

    User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

    • Terminated Z-1037-03 FDA Unclassified (pre-2012) initiated 23 May 2003 on shared 510(k) K953838

    Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K953838
  2. Recall initiated FDA recalls Z-1037-03
  3. Recall initiated FDA recalls Z-1924-2011
  4. Listed FDA GUDID 00634624501140
  5. Recall initiated FDA recalls Z-0361-2016
  6. Registered EUDAMED B-00634624501140

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MPS Arrest Agent Cassette EUDAMED
Mps GUDID
Generic name
Cardioplegia solution administration kit
Model / reference
5001104
Primary DI / UDI-DI
00634624501140
Basic UDI-DI
B-00634624501140
510(k) Number
FDA product code
DTR
EMDN code
C030102 Cardioplegia solution administration kits
GMDN term
Cardioplegia solution administration kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.4240
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cardioplegia solution administration kit

Cleared under the same submission (K953838)

and 8 more cleared under K953838

Similar devices in this category

Other devices filed under EXTRACORPOREAL ASSISTED CIRCULATION DEVICES.

Other devices from Quest Medical Inc

See all devices from Quest Medical Inc →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)