gudid Primary ID: MWS006

M Warmer System - Starter Kit+ (UDI MWS006)

Manufactured by Mequ A/S

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The M Warmer System - Starter Kit+ (Model/Catalog Number: MWS006) is a medical device manufactured by Mequ A/S. This product is indexed under FDA Product Code / Category Classification BSB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: MWS006
Product Code / EMDN: BSB
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).
Database Sync Date: 2026-08-09 09:12:36

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of M Warmer System - Starter Kit+?

The registered manufacturer of record for M Warmer System - Starter Kit+ is Mequ A/S.

What is the Primary UDI-DI identifier for M Warmer System - Starter Kit+?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MWS006.

What classification code is assigned to this device?

This device is registered under product classification code BSB.

Similar Classification Devices (BSB)

Other Devices by Mequ A/S

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