FDA.reportPublic FDA data

Hot/cold therapy pack, single-use

Definition
A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.
GUDID devices
350
Last updated
2025-09-22 17:07:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
40080196733737MEDLINEMEDLINE INDUSTRIES, INC.MDS1480652025-09-12
20888277659664MEDLINEMEDLINE INDUSTRIES, INC.MDS1370802025-09-12
40080196733362MEDLINEMEDLINE INDUSTRIES, INC.MDS1480102025-08-26
10860010472146Instant Cold Pack 6inx9inMedzah IndustriesSAM-10012025-08-11
20860012637410Instant Cold Pack 4.75x7Medzah IndustriesSAM-30002025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inMedzah IndustriesSAM-30012025-08-11
20860011917483MEDZAH INSTANT HOT PACKMedzah IndustriesSAM-20002025-07-30
20860012637403MEDZAH INSTANT HOT PACKMedzah IndustriesSAM-20012025-07-30
40080196719656MEDLINEMEDLINE INDUSTRIES, INC.MDS1380072025-07-01
00840456203828JMUJMU DENTAL, INC250010022025-06-13
30665973032581DUKALDukal LLC98452025-04-22
00612479277236McKessonMCKESSON MEDICAL-SURGICAL INC.IHP-572025-04-10
00612479277250McKessonMCKESSON MEDICAL-SURGICAL INC.IHP-692025-04-10
40080196733720MEDLINEMEDLINE INDUSTRIES, INC.MDS1480552025-04-07
D930250010020JMUJMU DENTAL, INC250010022025-02-21
00840314812667B-COOL COLD THERAPY WRAP UNIVHausmann Enterprises, LLCHM33302025-01-01
00840314812728"B-COOL CRYO WRAP 24"" W/2,2.0 PKS"Hausmann Enterprises, LLCHM33972025-01-01
00840314816023B-COOL KNEE WRAP W/2, 2.0 PKSHausmann Enterprises, LLCHM33822025-01-01
36976040710276LIFE WORKSHealth Plus (Shanghai) International Co., LTDLW00052024-12-08
46976040710273LIFE WORKSHealth Plus (Shanghai) International Co., LTDLW00062024-12-08
M68959300050HAWK Warming GridSafeguard US Operating, LLC052024-11-15
00810180840545DynaSafety Instant Cold Pack, 4" x 5" Dynarex Corporation4511UB-22024-03-08
10810132043311HCSConcordance Healthcare Solutions LLC1122S2024-09-13
00612479264847CareStockMCKESSON MEDICAL-SURGICAL INC.CS97022024-08-06
00612479264854CareStockMCKESSON MEDICAL-SURGICAL INC.CS97042024-08-06
00612479264861CareStockMCKESSON MEDICAL-SURGICAL INC.CS97062024-08-06
D930250010010JMUJMU DENTAL, INC250010012024-06-03
D930250010018JMUJMU DENTAL, INC250010012024-06-03
06975983272482MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.BF007_8pcs2024-05-21
06975983272499MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.BF007_16pcs2024-05-21
50681131403905EQUATEWAL-MART STORES, INC.4222662024-05-20
00194346210862equateWAL-MART STORES, INC.WMTICE-100J2024-03-29
00840117333215Instant Cold Pack, 4" x 5" DYNAREX CORPORATION4511UB-12024-03-29
00810110302099NuvoMedNUVOMED, INC.CTSS-12/02092024-03-22
00810110302105NuvoMedNUVOMED, INC.CTSL-12/02102024-03-22
00810110302112NuvoMedNUVOMED, INC.CTSX-12/02112024-03-22
00810110302129NuvoMedNUVOMED, INC.CTFP-6/02122024-03-22
20057475282732BIOS LivingThermor LtdLH2732024-03-21
20057475282749BIOS LivingThermor LtdLH2742024-03-21
20057475282756BIOS LivingThermor LtdLH2752024-03-21
20885632413862HalyardOWENS & MINOR DISTRIBUTION, INC.517872024-03-19
20885632413787HalyardOWENS & MINOR DISTRIBUTION, INC.517792024-03-11
08401173347862DynaSafety Instant Cold Pack, 4" x 5" DYNAREX CORPORATION4511UB-22024-03-08
40080196749882MedlineMEDLINE INDUSTRIES, INC.MDS1490102024-03-05
20885632413831HalyardOWENS & MINOR DISTRIBUTION, INC.517842024-03-04
20885632413848HalyardOWENS & MINOR DISTRIBUTION, INC.517852024-03-04
20885632413855HalyardOWENS & MINOR DISTRIBUTION, INC.517862024-03-04
20885632413879HalyardOWENS & MINOR DISTRIBUTION, INC.517882024-03-04
20885632413886HalyardOWENS & MINOR DISTRIBUTION, INC.517892024-03-04
20885632413923HalyardOWENS & MINOR DISTRIBUTION, INC.517932024-03-04
20885632413930HalyardOWENS & MINOR DISTRIBUTION, INC.517942024-03-04
20885632413947HalyardOWENS & MINOR DISTRIBUTION, INC.517952024-03-04
20885632413763HalyardOWENS & MINOR DISTRIBUTION, INC.517772024-03-01
20885632413770HalyardOWENS & MINOR DISTRIBUTION, INC.517782024-03-01
30885632413807HalyardOWENS & MINOR DISTRIBUTION, INC.517812024-03-01
20885632413725HalyardOWENS & MINOR DISTRIBUTION, INC.517742024-02-21
20885632413732HalyardOWENS & MINOR DISTRIBUTION, INC.517752024-02-21
20885632413749HalyardOWENS & MINOR DISTRIBUTION, INC.517762024-02-21
20885632413756HalyardOWENS & MINOR DISTRIBUTION, INC.517732024-02-21
80683534040016A PlusA PLUS INTERNATIONAL INC.12024-01-18
80683534040023A PlusA PLUS INTERNATIONAL INC.12024-01-18
80683534040030A PlusA PLUS INTERNATIONAL INC.12024-01-18
06975983272024MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.BF007_4PC2023-11-08
10311917047154WalgreensWALGREEN CO.6410342023-10-27
30840330703605ProCure™Twin Med, LLCPC12102023-10-04
30840330703612ProCure™Twin Med, LLCPC13012023-10-04
50192253061176CARDINAL HEALTHCardinal Health 200, LLC11440-012B2023-10-03
50192253061183CARDINAL HEALTHCardinal Health 200, LLC11440-512B2023-10-03
50192253061206CARDINAL HEALTHCardinal Health 200, LLC11443-012B2023-10-03
50192253061213CARDINAL HEALTHCardinal Health 200, LLC11443-512B2023-10-03
50192253061220CARDINAL HEALTHCardinal Health 200, LLC11445-020B2023-10-03
50192253061244CARDINAL HEALTHCardinal Health 200, LLC11450-040B2023-10-03
50192253061381NOVAPLUSCardinal Health 200, LLCV11440-9002023-10-03
50192253061398NOVAPLUSCardinal Health 200, LLCV11443-012B2023-10-03
50192253061404NOVAPLUSCardinal Health 200, LLCV11450-040B2023-10-03
50192253061411NOVAPLUSCardinal Health 200, LLCV11500-0102023-10-03
50885380193123CARDINAL HEALTHCARDINAL HEALTH 200, LLC102GVT2023-09-06
06950471300137DISPOSABLE HOT OR COLD PACK COVERHangzhou A-Tek Medical & Textiles Co., Ltd.280302023-07-21
50192253061251CARDINAL HEALTHCardinal Health 200, LLC11475-010B2023-06-19
20885380193214CARDINAL HEALTHCARDINAL HEALTH 200, LLC11460-010DISC2023-06-19