FDA.reportPublic FDA data

CVS Health

Primary DI
00050428328323
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
351297
Device description
Neck & Shoulder Heat Wrap
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
10050428328320PackageGS124In Commercial Distribution
00050428328323PrimaryGS10
60050428328325Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042832832010050428328320
00050428328323000504283283230504283283230050428328323
6005042832832560050428328325

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.

Contacts#

Phone, Email table
PhoneEmail
18007467287xx@xx.xx

Regulatory Flags#

DUNS number
062312574
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428049556CVS Health6 Days Sooner Pregnancy TestN/A2026-06-02
00050428142516CVS0504281425162026-05-28
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27
00050428142530CVS0504281425302026-04-23
00050428258590CVS Health8931212020-08-24
00050428265499CVS Health2414832020-02-28
00050428267189CVS Health9356862020-08-24
00050428279472CVS Health9843012020-03-02
00050428290118CVS Health8931262020-08-24
00050428307274CVS Health9356832020-08-24
00050428308615CVS Health5426302019-09-30
00050428311097CVS Health9356852020-08-24

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
00840117341067CozyTherm Heat Relief Patch, NeckDynarex 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