°M Warmer System - °M Warmer

FDA UDI

Class II (US FDA UDI)

by Mequ A/S

Identity

Trade Name: °M Warmer System - °M Warmer FDA UDI
Generic Name: Conduction blood/fluid warmer FDA UDI
Device Name: Disposable IV Fluid / Blood Warmer unit FDA UDI
Model / Reference: MWS201 FDA UDI
Description: Disposable IV Fluid / Blood Warmer unit FDA UDI

Identifiers

Catalog Number: MWS201 FDA UDI
Primary DI / UDI-DI: 05700002076816 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Conduction blood/fluid warmer

°M Warmer System - °M Warmer 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.

Ranger™ — 3M COMPANY · Class II
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 044093ba-8ddf-4334-a23d-ed5a34c13186 36 fields · synced Jun 8, 2026