°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…

Registry build 21.09.26

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.

1manufacturer
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LGZ
Manufacturer City Province Registered as Device types
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24

Record

Regulatory record for °M Warmer System – °M Station
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

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 numbers for °M Warmer System – °M Station
Catalogue number Size Status
MWS405 In distribution
MWS406 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer