# Mps 5001102

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/mps-5001102>
- Manufacturer: [Quest Medical Inc](https://devicerts.com/manufacturers/quest-medical-inc) (United States)
- Name in the registry: MPS 5001102
- Device class: Class IIa (EU MDD); Class II (US FDA)
- FDA product code: DTR
- EMDN: C030102 CARDIOPLEGIA SOLUTION ADMINISTRATION KITS
- GMDN: Cardioplegia solution administration kit (16163)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00634624501126 · UDI-DI 00634624501126 · registered 2026-09-15 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00634624501126 · listed 2015-09-16 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K953838 · decision 1996-03-06 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0361-2016 · Class II · terminated · initiated 2015-10-28: The products have been found to intermittently exhibit a seal failure during use.
- Z-1924-2011 ·  · terminated · initiated 2010-07-29: User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
- Z-1037-03 ·  · terminated · initiated 2003-05-23 · matched through shared submission K953838, may concern other models: Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.

## Identity

- Trade name: MPS Delivery Set (w/ heat exchanger, arrest & additive cassettes, 3m extension lines) [EUDAMED]; MPS [FDA GUDID (AccessGUDID)]
- Generic name: Cardioplegia solution administration kit [FDA GUDID (AccessGUDID)]
- Model / reference: 5001102 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00634624501126 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00634624501126 [EUDAMED]
- 510(k) Number: K953838 [FDA GUDID (AccessGUDID)]
- FDA product code: DTR [FDA GUDID (AccessGUDID)]
- EMDN code: C030102 [EUDAMED]
- GMDN term: Cardioplegia solution administration kit (16163) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 870.4240 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Italy [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Contains animal tissues or cells: Yes [EUDAMED]
- Administering medicine: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Mps 5001102, Quest Medical Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/mps-5001102 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/mps-5001102.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/mps-5001102
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.