Warmer, Thermal, Infusion Fluid

FDA product code LGZ · 74 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5725
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1981-05-21 – 2026-09-18

LGZ 2026-09-18

NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)

Applicant ICU Medical

K number K262532

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LGZ 2026-04-24

°M Warmer System with °M Station

Applicant Mequ A/S

K number K260988

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LGZ 2025-11-18

Fluido Compact System

Applicant The Surgical Company International B.V.

K number K252636

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LGZ 2025-09-04

Fluido® AirGuard System

Applicant The Surgical Company International BV (As Tsc Life)

K number K251733

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LGZ 2024-05-31

°M Warmer System

Applicant Mequ A/S

K number K232107

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LGZ 2023-06-05

Fluido Compact Blood and Fluid Warming System

Applicant The Surgical Company International B.V.

K number K211618

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LGZ 2022-12-08

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K number K211800

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LGZ 2022-08-12

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System

Applicant Smisson-Cartledge Biomedical, LLC

K number K202461

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LGZ 2022-05-24

S-Line

Applicant Barkey GmbH & Co. KG

K number K213191

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LGZ 2019-10-18

Quantum Blood and Fluid Warming System

Applicant Life Warmer, Inc.

K number K192325

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LGZ 2019-03-05

MAC Medical D-Series Blanket and Solution Warming Cabinets

Applicant Mac Medical, Inc.

K number K180842

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LGZ 2019-01-28

Quantum Blood and IV Fluid Infusion Warmer

Applicant Life Warmer, Inc.

K number K181775

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LGZ 2018-04-27

QiF Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K number K180154

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LGZ 2017-09-27

QiF Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K number K171215

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LGZ 2017-04-20

QiF Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K number K163708

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LGZ 2016-12-28

Hang&Go PAC

Applicant Rand S.R.L.

K number K161613

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LGZ 2016-06-23

QiF Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K number K150404

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LGZ 2013-12-06

DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET

Applicant Enthermics Medical Systems, Inc.

K number K132202

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LGZ 2013-11-06

BELMONT HYPERTHERMIA PUMP

Applicant Belmont Instrument Corp.

K number K131519

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LGZ 2013-10-03

NATUS WARMETTE BLANKET AND DUAL CABINETS

Applicant Natus Nicolet Ireland, Ltd.

K number K132110

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LGZ 2013-06-14

ENFLOW IV FLUID WARMER INSULATED STRAP

Applicant Vital Signs, Inc., A GE Healthcare Company

K number K130867

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LGZ 2013-06-13

ENTERAL NUTRITION WARMER

Applicant Acacia, Inc.

K number K122449

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LGZ 2012-11-28

ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER

Applicant Vital Signs, Inc., A GE Healthcare Company

K number K121775

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LGZ 2012-07-12

BW685, BW685S

Applicant Biegler GmbH

K number K121198

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LGZ 2012-05-08

INFU BOX TYPE 0412A

Applicant Medical Rescue Equipment Holding AS

K number K120860

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LGZ 2012-05-08

PERFORMER HT/ HANG&GO HT BASIC

Applicant Rand S.R.L.

K number K120026

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LGZ 2012-03-29

IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS

Applicant Imperial Surgical , Ltd.

K number K112702

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LGZ 2012-03-21

HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM

Applicant Hei, Inc.

K number K102900

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LGZ 2012-03-14

ENFLOW IV FLUID WARMER

Applicant Vital Signs, Inc.

K number K112902

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LGZ 2011-07-29

AMSCO WARMING CABINET

Applicant STERIS Corporation

K number K111870

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LGZ 2011-06-03

AMSCO WARMING CABINET

Applicant STERIS Corporation

K number K110769

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LGZ 2011-05-20

HYPOTHERMX INTRAVENOUS FLUID WARMER

Applicant Emit Corporation

K number K103801

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LGZ 2010-05-07

IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V

Applicant Enthermics Medical Systems, Inc.

K number K091336

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LGZ 2010-03-04

TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE

Applicant Thermal Therapeutic Systems, Inc.

K number K092366

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LGZ 2009-12-18

AMSCO WARMING CABINET

Applicant STERIS Corporation

K number K092823

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LGZ 2009-02-12

BELMONT HYPERTHERMIA PUMP

Applicant Belmont Instrument Corp.

K number K090089

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LGZ 2008-12-18

ASTOFLO PLUS

Applicant Stihler Electronic GmbH

K number K082765

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LGZ 2008-10-06

RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM

Applicant Arizant Healthcare, Inc.

K number K082217

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LGZ 2008-06-02

NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,

Applicant Smiths Medical Asd, Inc.

K number K072080

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LGZ 2008-03-20

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300

Applicant Paladin Biomedical Corporation

K number K073363

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LGZ 2007-09-11

FLEXWARMER, MODELS KZ-1 AND KZ-2

Applicant Merlyn Associates, Inc.

K number K062644

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LGZ 2007-06-08

HYPERTHERMIA PUMP

Applicant Belmont Instrument Corp.

K number K070654

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LGZ 2006-12-22

SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER

Applicant The Smithworks Company

K number K060851

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LGZ 2006-10-26

SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200

Applicant Smisson-Cartledge Biomedical, LLC

K number K052055

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LGZ 2006-06-26

RANGER IRRIGATION FLUID WARMING SYSTEM

Applicant Arizant Healthcare, Inc.

K number K060939

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LGZ 2006-06-08

EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

Applicant Enginivity, LLC

K number K060537

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LGZ 2005-02-15

8NONE

Applicant Medical Solutions, Inc.

K number K041839

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LGZ 2003-09-22

LARGE VOLUME FLUID RESERVOIR

Applicant Belmont Instrument Corp.

K number K032778

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LGZ 2003-09-16

BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000

Applicant Belmont Instrument Corp.

K number K032674

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LGZ 2003-07-23

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712

Applicant Minimed, Inc.

K number K031390

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LGZ 2003-01-28

MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

Applicant Elltec Co., Ltd.

K number K024373

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LGZ 2003-01-17

MAXONE IV FLUID/BLOOD WARMER, MODEL 102

Applicant Automatic Medical Technologies, Inc.

K number K023653

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LGZ 2001-10-24

COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

Applicant Nxstage Medical, Inc.

K number K012832

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LGZ 2001-10-09

ANIMEC, MODELS AM-2S-4 AND AM-2S-5

Applicant Elltec Co., Ltd.

K number K012906

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LGZ 2001-08-20

TEMP 3

Applicant Medical Solutions, Inc.

K number K012276

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LGZ 2001-06-28

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

Applicant Automatic Medical Technologies, Inc.

K number K002409

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LGZ 2000-08-09

HOTLINE 2 FLUID WARMER

Applicant Sims Level 1, Inc.

K number K001764

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LGZ 1998-07-10

TEMPO III

Applicant Medical Products, Inc.

K number K981509

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LGZ 1998-03-10

HEAT STACK

Applicant Medical Solutions, Inc.

K number K980086

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LGZ 1998-03-10

TEMPO AND TEMP H20

Applicant Smith

K number K973748

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LGZ 1996-08-08

BIEGLER BW385L BLOOD & INFUSION WARMER

Applicant Biegler Medical Products, Inc.

K number K954769

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LGZ 1996-05-14

DRUGBOX

Applicant C.F. Electronics, Inc.

K number K955659

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LGZ 1993-01-27

THERM O DRUG MODEL HT-747

Applicant C.F. Electronics, Inc.

K number K922786

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LGZ 1992-10-23

QWIK-1(TM) IN-LINE IV FLUID WARMER

Applicant Microwave Medical Systems, Inc.

K number K914867

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LGZ 1992-09-10

ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.

Applicant North American Technical Services Corp.

K number K914364

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LGZ 1992-09-02

HOT SACK

Applicant C.F. Electronics, Inc.

K number K921395

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LGZ 1991-10-17

HOTLINE FLUID WARMER

Applicant Level 1 Technologies, Inc.

K number K911383

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LGZ 1990-10-15

HEATWAVE

Applicant Medadvances, Inc.

K number K904252

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LGZ 1990-02-09

BIOTEMP

Applicant Medadvances, Inc.

K number K896018

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LGZ 1989-02-28

INFUSION FLUID WARMER

Applicant Pmt Corp.

K number K883873

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LGZ 1988-08-25

STIHLER ASTOTHERM IFT 200, IFT 220

Applicant Stihler Electronic, C/O Worldwide Regul. Services

K number K882361

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LGZ 1982-08-20

BT 794-BLOOD/FLUID WARMER

Applicant Electromedics, Inc.

K number K822098

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LGZ 1981-12-09

FLO TEM II (BLOOD/FLUID WARMER

Applicant Datachem, Inc.

K number K813161

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LGZ 1981-05-21

FLUID WARMER

Applicant Datachem, Inc.

K number K803249

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