Pack, Hot Or Cold, Disposable

FDA product code IMD · 82 cleared devices

Class 1 Physical Medicine

Regulation: 21 CFR 890.5710
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-09-16 – 2022-10-06

IMD 2022-10-06

InfaTherm Disposable Infant Warming Mattress

Applicant International Biomedical

K number K221653

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IMD 2017-07-24

Infant Transport Mattress Warmer with Disc

Applicant Rapid Aid Corp.

K number K163295

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IMD 2012-03-06

NEO NEST

Applicant Denovo Proucts, LLC

K number K112547

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IMD 2008-09-11

EYEFEEL OPHTHALMIC WARMER

Applicant Bio-Lipid, Inc.

K number K082087

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IMD 2007-08-14

BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)

Applicant Johnson & Johnson Consumer Products, Inc.

K number K071710

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IMD 2002-09-03

EYEFEEL OPHTHALMIC WARMER

Applicant Bio-Lipid, Inc.

K number K021843

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IMD 1999-01-21

ALLEGIANCE PORTA-WARM MATTRESS

Applicant Allegiance Healthcare Corp.

K number K982652

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IMD 1998-02-26

DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS

Applicant Deroyal Industries, Inc.

K number K980509

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IMD 1997-11-19

CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER

Applicant Consolidated Products & Services, Inc.

K number K974190

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IMD 1997-11-13

ALLEGIANCE KWIK HEAT WARM PERINEAL PACK

Applicant Allegiance Healthcare Corp.

K number K973770

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IMD 1997-04-03

KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)

Applicant Allegiance Healthcare Corp.

K number K970399

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IMD 1996-12-12

RECOVER ADULT VEIN WARMER

Applicant Florida Medical Industries, Inc.

K number K963689

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IMD 1996-11-25

INSTANT HOT PACKS

Applicant Kick Ice, Inc.

K number K963768

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IMD 1996-10-30

INSTANT COLD PACK

Applicant Kick Ice, Inc.

K number K963666

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IMD 1996-10-10

TEMPRA COLD PACK, REORDER NO. TC150

Applicant Tempo Technology, Inc.

K number K963220

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IMD 1996-09-04

OMNI COLD GEL PACKS

Applicant Omni Therm, Inc.

K number K961176

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IMD 1996-09-04

IMNI HOT PACKS

Applicant Omni Therm, Inc.

K number K955788

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IMD 1996-08-15

ANDELA DYNAMIC COOLING DEVICE

Applicant Candela Laser Corp.

K number K951033

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IMD 1996-05-06

CERTI COOL INSTANT COLD COMPRESS

Applicant Certified Safety Mfg., Inc.

K number K960624

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IMD 1996-02-13

OMNI COLD GEL PACKS

Applicant Omni Therm, Inc.

K number K954877

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IMD 1995-10-31

RESTORE, THERMACELLS (HOT PACK I)

Applicant Neal Dunning Assoc., Inc.

K number K953442

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IMD 1995-10-30

COLDGEL

Applicant Prism Technologies, Inc.

K number K953542

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IMD 1995-10-05

INSTANT COLDGEL

Applicant Prism Technologies, Inc.

K number K953541

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IMD 1995-08-23

INFANT HEEL WARMER

Applicant Baxter Healthcare Corp

K number K950680

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IMD 1995-06-01

TEMPRA HEAT PACK

Applicant Tempra Technology, Inc.

K number K951383

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IMD 1994-05-02

POLY-MEDICS HEAT PACK

Applicant Biomet, Inc.

K number K941245

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IMD 1994-03-31

OMNI WARM GEL PACKS

Applicant Omni Therm, Inc.

K number K936084

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IMD 1994-03-07

CERTI HEAT INSTANT HEAT COMPRESS

Applicant Certified Safety Mfg., Inc.

K number K940336

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IMD 1994-03-07

INSTANT HOT OR COLD DISPOSABLE PACK

Applicant Cryopak Industries, Inc.

K number K935569

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IMD 1994-02-03

TRANSWARMER

Applicant Prism Technologies, Inc.

K number K934631

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IMD 1994-02-02

KACEY DISPOSABLE INFANT HEEL WARMER

Applicant K & C Medical, Inc.

K number K934673

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IMD 1993-07-29

PERI-K PAD COLD PACK

Applicant Baxter Healthcare Corp

K number K920760

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IMD 1993-05-26

ANAGO DISPOSABLE INSTANT COLD PACK

Applicant Anago, Inc.

K number K926590

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IMD 1993-05-26

ANAGO WARM PACK

Applicant Anago, Inc.

K number K926589

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IMD 1993-05-26

ANAGO FEM-COOL/FEM-COOL PETITE

Applicant Anago, Inc.

K number K926137

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IMD 1992-02-11

CURAD KID SIZE INSTANT COLD PACK

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K920252

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IMD 1991-10-02

INSTANT WARM GEL PACK

Applicant Prism Technologies, Inc.

K number K912715

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IMD 1990-12-06

SHUR-LOCK ICE WRAP SYSTEM

Applicant Conco Medical Co.

K number K904819

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IMD 1990-07-25

LIBERTY HOT PACK AND LIBERTY KOLD PACK

Applicant Liberty Ent.

K number K902839

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IMD 1990-05-03

INSTANT ICE PACK

Applicant Impact Packaging Corp.

K number K901834

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IMD 1990-05-01

3M HEAT COMFORT PORTABLE SELF-HEATING PAD

Applicant 3M Company

K number K901778

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IMD 1990-01-02

MEDI-PACK

Applicant Heatmax Mfg., Inc.

K number K895860

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IMD 1989-09-05

STAT-PAD

Applicant Hettel Accessories, Inc.

K number K894926

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IMD 1989-03-14

THERMO-PACK

Applicant Medical Manufacturers, Inc.

K number K890924

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IMD 1989-02-13

CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS

Applicant Consolidated Products & Services, Inc.

K number K890554

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IMD 1989-02-13

CP&S DISPOSABLE INSTANT COLD COMPRESS

Applicant Consolidated Products & Services, Inc.

K number K890553

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IMD 1988-09-30

HARE COLD PACK

Applicant Dyna Industries, Inc.

K number K883966

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IMD 1988-05-20

GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER

Applicant John Wagner Associates, Inc.

K number K880871

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IMD 1987-11-17

HYPERTHERM TECHNOLOGIES' HEAT COMPRESS

Applicant Hypertherm Technologies, Inc.

K number K873364

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IMD 1987-04-06

INSTANT COLD COMPRESS, CHEMICAL TYPE

Applicant Lexington Industries

K number K871168

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IMD 1987-03-25

INSTANT HEAT COMPRESS, CHEMICAL TYPE

Applicant Lexington Industries

K number K871114

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IMD 1987-03-12

OXY-THERM

Applicant M.D. Intl., Inc.

K number K870832

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IMD 1986-09-19

PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS

Applicant Physician & Nurses Mfg. Corp.

K number K863507

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IMD 1986-02-27

MAZING HEAT DISPOSABLE WARM PACK

Applicant Leebryan Intl.

K number K860444

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IMD 1985-09-25

HOT OR HEAT PACK

Applicant Matrix Intl.

K number K853148

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IMD 1985-09-06

ALLY PORTABLE NOT PACK/PAD DISPOSABLE

Applicant Actin International, Inc.

K number K853045

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IMD 1985-08-12

HOT PACK

Applicant Oriental Medical Supplies, Inc.

K number K852610

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IMD 1985-05-29

MARUKYR-BAN / HOT OR HEAT PACK

Applicant Oriental Medical Supplies, Inc.

K number K850566

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IMD 1985-04-25

EXOTHERMIC HEATING PAD

Applicant Travenol Laboratories, S.A.

K number K850637

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IMD 1984-11-23

EIXO THERMUS HEATING PADS

Applicant Eixo Thermus

K number K844224

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IMD 1982-05-13

SPENCO CRYOPRESS

Applicant Spenco Medical Corp.

K number K820906

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IMD 1982-04-29

COMPRES PORTABLE HEAT PADS

Applicant S.C. Johnson & Son, Inc.

K number K821046

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IMD 1982-03-08

HOT MINI 15 & HOT MINI 24

Applicant Hot Mini International, Inc.

K number K820359

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IMD 1982-02-12

ACE BRAND INSTANT COLD PACK

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K820282

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IMD 1982-01-19

BK-7182 INSTANT COLD PACK

Applicant Fred Sammons, Inc.

K number K813628

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IMD 1981-07-31

JAPANESE HOTZIE

Applicant Consolidated Health & Sports Prod.

K number K811803

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IMD 1981-05-21

SELF HEATING DISPOSABLE HEAT PAD

Applicant Ensar Corp.

K number K811206

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IMD 1981-03-26

CURITY PERINEAL COLD PACK

Applicant The Kendal Co.

K number K810693

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IMD 1981-03-26

CURITY PERINEAL WARM PACK

Applicant The Kendal Co.

K number K810692

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IMD 1981-03-26

WONDER WARMER

Applicant Montvale Products, Inc.

K number K810633

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IMD 1980-10-03

HOT CYCLE, A CHEMICAL TYPE HOT PACK

Applicant Signal West

K number K802252

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IMD 1979-09-07

INSTANT HOT & COLD PACKS

Applicant Chase Mfg. Co.

K number K790993

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IMD 1979-09-04

KWICK KOOLER

Applicant Stahlex Corp.

K number K791675

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IMD 1979-04-03

TULANE HEAT-PACK

Applicant Tulane

K number K790480

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IMD 1978-04-27

BODY WARMER

Applicant Q-Matic Corp.

K number K780426

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IMD 1978-04-21

COLD PACK

Applicant Abco Dealers, Inc.

K number K780603

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IMD 1978-04-10

ICE-PAK, PDI

Applicant Nice-Pak Products, Inc.

K number K780279

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IMD 1978-02-21

COLD CYCLE, CHEMICAL COLD PACK

Applicant Signal West

K number K780014

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IMD 1977-11-07

KWICK KOOLER

Applicant World Trade Assoc.

K number K771660

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IMD 1977-04-05

SHAKE-N-WARM

Applicant Signal West

K number K770505

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IMD 1976-10-06

MUL-T-PAD

Applicant Gaymar Industries, Inc.

K number K760706

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IMD 1976-09-16

BODY WARMER (SHAKE-N-WARM)

Applicant Yamada Co., Ltd of Japan

K number K760441

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