FDA.reportPublic FDA data

CozyTherm Heat Relief Patch, Neck

Primary DI
00840117341067
Brand
CozyTherm Heat Relief Patch, Neck
Company
Dynarex Corporation
Model
1458
Published
2025-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
OMWAdhesive Backed Thermal Skin Patches

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMWAdhesive Backed Thermal Skin PatchesPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117341005PackageGS110In Commercial Distribution
00840117341036PackageGS13In Commercial Distribution
00840117341067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117341005008401173410058401173410050840117341005
00840117341036008401173410368401173410360840117341036
00840117341067008401173410678401173410670840117341067

GMDN Terms#

Term, Definition table
TermDefinition
Exothermic heat therapy pack/patchA device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117320925Resp-O2 Incentive Spirometer. Tri-Flow Chamber361022021-04-22
00840117324510Dynarex Bari + Max Bariatric HD Composit Swing Down Rail129542022-11-01
00616784295015Metal Swing Rail129502022-05-09
00616784295114Composite Swing Rail129512022-05-09
00616784295213Q Assist Bar129522022-05-09
00616784295312Pivot Assist Bar129532022-05-09
00616784296012Universal Rotating Assist Bar129602022-05-09
00616784296111Universal Pivot Assist Bar129612022-05-09
00840117303478Expansion Kit for D300129142022-05-09
00840117348578Standard Sling Seat/Back Sling, Mesh10750MS2019-12-30
00840117348592Standard Sling Seat/Back Sling, Canvas10750CN2019-12-30
00840117348615Standard Sling Seat/Back Sling, Mesh With Commode Opening10751MS2019-12-30
00840117348639Standard Sling Seat/Back Sling, Canvas With Commode Opening10751CN2019-12-30
00840117348653Standard Seat/Back Sling - Canvas, Adult Large107522019-12-30
00616784075419Replacement Straps For Standard Slings107542021-04-19
00840117324527Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54"120142022-11-21
00840117302891Long-Term Care Bed, D100120012021-02-03
00840117302907Long Term Care Bed, D200120022021-02-03
00840117302914Long-Term Care Bed D300, 5 Function Low Bed120032021-02-03
00840117302945Bariatric HD Long-Term Care Bed, DB300, 5 Function Low Bed120132021-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00383568101618EZflex Lidocaine 4% pain relief patch 5 countCare Living Diagnostics Inc.OMW2025-11-04
00383568101625EZflex Lidocaine 4% & Menthol 1% pain relief patch 5 countCare Living Diagnostics Inc.OMW2025-11-04
06945397906167Up&UpTARGET CORPORATIONOMW2025-09-05
06945397906174Up&UpTARGET CORPORATIONOMW2025-09-05
06959962439011Pain Relief PatchHunan Jianyuan Medical Science And Technology Co., Ltd.OMW2025-02-28
00840117341043CozyTherm Heat Relief Patches MenstrualDynarex CorporationOMW2025-02-13
00840117341050CozyTherm Heat Relief Wrap, BackDynarex CorporationOMW2025-02-13
00072959010799UricalmAlva/Amco Pharmacal Companies, Inc.OMW2024-12-20
60072959010791UricalmAlva/Amco Pharmacal Companies, Inc.OMW2024-12-20
00072959019747BackAidAlva/Amco Pharmacal Companies, Inc.OMW2024-11-29
00681131403900EQUATEWAL-MART STORES, INC.OMW2024-05-20
50681131403905EQUATEWAL-MART STORES, INC.OMW2024-05-20
06945397906181Up&UpTARGET CORPORATIONOMW2024-02-28
06945397906198Up&UpTARGET CORPORATIONOMW2024-02-28
00057475363055BIOS DiagnosticsThermor LtdOMW2023-12-08
20057475363059BIOS DiagnosticsThermor LtdOMW2023-12-08
00072959015749BackAidAlva/Amco Pharmacal Companies, Inc.OMW2023-05-01
60072959015741BackAidAlva/Amco Pharmacal Companies, Inc.OMW2023-05-01
00049696869737N/AFOURSTAR GROUP INC.OMW2023-02-05
00810084939406FifthPulseJeg & Sons Inc.OMW2022-12-16
00810084939413FifthPulseJeg & Sons Inc.OMW2022-12-16
06974567749631Rhino RescueWuxi Emsrun Technology Co., Ltd.OMW2022-12-08
10850046230223Future Generation Medical Global International L. L. C.OMW2022-11-13
10850046230230Future Generation Medical Global International L. L. C.OMW2022-11-13
30850046230289Future Generation Medical Global International L. L. C.OMW2022-11-13
60850046230297FG-HCP0916Global International L. L. C.OMW2022-11-13
00850046230226Future Generation Medical Global International L. L. C.OMW2022-11-13
00850046230233Future Generation Medical Global International L. L. C.OMW2022-11-13
00850046230288Future Generation Medical Global International L. L. C.OMW2022-11-13
00850046230295FG-HCP0916Global International L. L. C.OMW2022-11-13