°m Warmer System – Power Pack
The °M Warmer power pack supplies electrical energy to the compatible portable fluid warmer. It is a rechargeable battery component used with the system’s disposable warming unit. The…
The °M Warmer power pack supplies electrical energy to the compatible portable fluid warmer. It is a rechargeable battery component used with the system’s disposable warming unit. The connected warmer heats blood, blood products, colloid or crystalloid solutions before infusion.
The battery pack is reusable for multiple patients, with its remaining power indicated during use. It powers the warming unit’s resistive heating elements, while the warming unit’s electronics regulate the temperature of the fluid leaving the heating chamber.
Listed Item
Rechargeable battery pack for powering the °M Warmer
Charging and Use
A compatible reusable charger replenishes the pack when depleted. The system is intended for healthcare professionals in hospitals, clinics and field settings, including road and air ambulances. The pack requires the compatible warmer to perform fluid heating.
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) | K232107 |
| Record published | 2024-10-09 |
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; Storage environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MWS105 | 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.