°m Warmer System – °m Station
The °M Station is a reusable AC power supply for the °M Warmer fluid-warming system. It provides continuous mains power to the separate disposable warmer during use in hospitals, clinics or…
The °M Station is a reusable AC power supply for the °M Warmer fluid-warming system. It provides continuous mains power to the separate disposable warmer during use in hospitals, clinics or road ambulances.
The single-use warmer connects into an infusion line through luer-lock fittings. Resistive heating elements warm fluid passing through a parylene-coated aluminum chamber, with onboard electronics controlling the chamber and outgoing-fluid temperature.
Listed Item
AC mains power supply for powering the °M Warmer
Separate Component Roles
The station supplies electrical power and is intended for multipatient use. The warmer contains the sterile fluid pathway and is replaced after use. Together they warm blood, blood products, colloid or crystalloid solutions before administration, with the station providing the transportable mains-power option.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Mequ A/S, Denmark |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K260988 |
| Record published | 2026-07-02 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 60 to 106 KiloPascal; Storage environment temperature -20 to 50 °C; Handling environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MWS405 | In distribution | |
| MWS406 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pedigo Products, Inc. | Pedigo Products, Inc. | 207 |
| Amsco | Steris Corporation | 38 |
| Level 1 | ICU Medical, Inc | 26 |
| Skytron warming cabinet | Skytron, LLC | 24 |
| ThermaCor 1200 Infusion System | Smisson-Cartledge Biomedical LLC | 11 |
| Astoflo® Plus ECO | Stihler Electronic Gmbh | 10 |
| enFlow | Carefusion | 8 |
| Fluido® AirGuard System | The Surgical Company International B.V. | 7 |
| Smithworks Medical, Inc. | Smithworks, Inc. | 5 |
| Warming Cabinet Single Compartment Counter-Top Model (Glass Door) | Imperial Surgical Ltd. | 4 |
| Hang&Go PAC | Rand SPA | 4 |
| enFlow™ | Airlife, Inc. | 4 |
Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260988 | 2026-04-24 |
| K232107 | 2024-05-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.