# 3C Patch® Kit - Box 1

> Listed: FDA GUDID listing, not in commercial distribution. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/3c-patch-r-kit-box-1>
- Manufacturer: [Reapplix ApS](https://devicerts.com/manufacturers/reapplix-aps) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: PMQ
- GMDN: Haematological concentrate system preparation kit, platelet concentration (46923)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 05714188505541 · listed 2018-07-19 · status: Listed (GUDID: not in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: 3C Patch® Kit - Box [FDA GUDID (AccessGUDID)]
- Generic name: Haematological concentrate system preparation kit, platelet concentration [FDA GUDID (AccessGUDID)]
- Model / reference: 1 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05714188505541 [FDA GUDID (AccessGUDID)]
- FDA product code: PMQ [FDA GUDID (AccessGUDID)]
- GMDN term: Haematological concentrate system preparation kit, platelet concentration (46923) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 864.9245 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: Not in Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: 3C Patch® Kit - Box 1, Reapplix ApS. deviCERTS medical device catalogue. https://devicerts.com/devices/3c-patch-r-kit-box-1 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/3c-patch-r-kit-box-1.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/3c-patch-r-kit-box-1
- 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.