FDA.reportPublic FDA data

CVS Health

Primary DI
10050428328320
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
Rx
false
OTC
true
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18007467287xx@xx.xx

Regulatory Flags#

DUNS number
062312574
Device count
3
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428005873CVS695540BC332025-11-19
00050428280669CVS HealthCVS5248V12026-06-04
00050428359112CVS HealthCVS739091V12026-06-04
00050428453599CVS HealthCVS9107552026-06-04
10050428265106CVS Glucose Meter8000-107532021-03-22
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
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

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