°M Warmer System - Starter Kit+

FDA UDI

Class II (US FDA UDI)

by Mequ A/S

Identity

Trade Name: °M Warmer System - Starter Kit+ FDA UDI
Generic Name: Conduction blood/fluid warmer FDA UDI
Device Name: The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack+ (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140046) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847). FDA UDI
Model / Reference: MWS006 FDA UDI
Description: The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack+ (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140046) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847). FDA UDI

Identifiers

Catalog Number: MWS006 FDA UDI
Primary DI / UDI-DI: 05745000140022 FDA UDI
510(k) Number: K232107 FDA UDI
FDA Product Code: BSB FDA UDI
LGZ FDA UDI
GMDN Term: Conduction blood/fluid warmer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9205 FDA UDI
880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Conduction blood/fluid warmer

°M Warmer System - Starter Kit+ by Mequ A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conduction blood/fluid warmer.

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ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
ASTOLINE — Stihler Electronic GmbH · Class II
ASTOTHERM® PLUS — Stihler Electronic GmbH · Class II
EXPRESS FLUID WARMER — NxStage Medical, Inc. · Class II
ASTOFLO® PLUS ECO — Stihler Electronic GmbH · Class II
QINFLOW AC STATION INTRO SET WARRIOR — QUALITY IN FLOW LTD · Class II

Cleared under the same submission

K232107 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mequ A/S

Sources (1)

FDA UDI c4a3ad9d-7f94-459b-bfe8-9bad9978586a 36 fields · synced Jun 8, 2026