FDA.reportPublic FDA data

CVS Health

Primary DI
10050428437060
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
259349
Device description
Back & Hip Heat Wrap L-XL
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
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10050428437060PackageGS124In Commercial Distribution
00050428437063PrimaryGS10
60050428437065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042843706010050428437060
00050428437063000504284370630504284370630050428437063
6005042843706560050428437065

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
2
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
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
20050428020849CVS HealthCVS376561V22026-03-23
00050428339770CVS Health16CVS015073291982026-03-20
10050428001025CVS 797412BM22-12026-02-27
00050428005408CVS 841855WF032026-02-13
00050428005415CVS 845712WF132026-02-13
00050428005422CVS 837160WF232026-02-13
40050428029495CVS6354782026-02-13
00050428057186CVSHealth1017042026-02-04
00050428073421CVSHealth1044172026-02-04
00050428080863CVSHealth1059932026-02-04
00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00080196732343MEDLINEMEDLINE INDUSTRIES, INC.IMD2026-03-19
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08806109102551Madeca Summer Aroma PatchDongkook Pharmaceutical Co.,Ltd.IMD2026-02-19
08806109102568Madeca Summer Aroma PatchDongkook Pharmaceutical Co.,Ltd.IMD2026-02-19
00885914107966Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107973Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107980Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107997Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108000Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108017Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108024Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108031Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108055Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
30665973032611DukalDukal LLCIMD2025-10-31
30665973032628DukalDukal LLCIMD2025-10-31
30860013591930Vpod EliteCool Comforts Co.IMD2025-09-24
40080196733737MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
20888277659664MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
00850056748490FORWARD HEAT - Life GuardINTEGRATED MEDCRAFT LLCIMD2025-09-02
40080196733362MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-08-26
10860010472146Instant Cold Pack 6inx9inMedzah IndustriesIMD2025-08-11
20860012637410Instant Cold Pack 4.75x7Medzah IndustriesIMD2025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inMedzah IndustriesIMD2025-08-11
20860011917483MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
20860012637403MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
00850073571125American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-28
00850073571071American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-09
00840456203828JMUJMU DENTAL, INCIMD2025-06-13
16977244725048HetaidaLinqing HeTaiDa Medical Technology Co., LtdIMD2025-05-12
30860013591909VpodCool Comforts Co.IMD2025-05-02