# CombiStar Plus Filter flex MP12063

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

- Canonical page: <https://devicerts.com/devices/combistar-plus-filter-flex-mp12063>
- Manufacturer: [Drägerwerk AG & Co. KGaA](https://devicerts.com/manufacturers/dragerwerk-ag-and-co-kgaa) (Germany)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: CAH
- EMDN: R020202 MOBILE CATHETER MOUNTS
- EMDN: R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
- GMDN: Breathing circuit catheter mount, single-use (42476)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 0404867512080296K1QZ00063 · UDI-DI 04048675714446 · registered 2026-08-17 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 04048675714446 · listed 2024-10-07 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K221836 · decision 2022-12-07 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2158-2025 · Class I · ongoing · initiated 2025-06-16: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Z-2159-2025 · Class I · ongoing · initiated 2025-06-16: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Z-2161-2025 · Class I · ongoing · initiated 2025-06-16: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Z-2160-2025 · Class I · ongoing · initiated 2025-06-16: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

## Identity

- Trade name: CombiStar Plus Filter flex [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Breathing circuit catheter mount, single-use [FDA GUDID (AccessGUDID)]
- Model / reference: MP12063 [EUDAMED, FDA GUDID (AccessGUDID)]; 2080296K1QZ000 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 04048675714446 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 0404867512080296K1QZ00063 [EUDAMED]
- 510(k) Number: K221836 [FDA GUDID (AccessGUDID)]
- FDA product code: CAH [FDA GUDID (AccessGUDID)]
- EMDN code: R020202 [EUDAMED]; R040102 [EUDAMED]
- GMDN term: Breathing circuit catheter mount, single-use (42476) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 868.5260 [FDA GUDID (AccessGUDID)]
- System or procedure pack: Procedure pack [EUDAMED]
- EU registration type: System or procedure pack [EUDAMED]
- Medical purpose: The medical purpose of the Pack2Go/Combistar is to support respiratory and anesthetic therapy by ensuring the provision of functionally compatible, and ready-to-use accessories. [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- 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: CombiStar Plus Filter flex MP12063, Drägerwerk AG & Co. KGaA. deviCERTS medical device catalogue. https://devicerts.com/devices/combistar-plus-filter-flex-mp12063 (data as of 2026-11-15).
- 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: 2026-11-12
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/combistar-plus-filter-flex-mp12063.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/combistar-plus-filter-flex-mp12063
- 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.