FDA.reportPublic FDA data

CVSHealth

Primary DI
00050428284537
Brand
CVSHealth
Company
FOURSTAR GROUP INC.
Model
64408659Y
Device description
MOIST HEAT COMPRESS
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IMAPack, Heat, Moist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMAPack, Heat, MoistPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00050428284537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428284537000504282845370504282845370050428284537

GMDN Terms#

Term, Definition table
TermDefinition
Moist-heat packA device intended to be applied with pressure to the body surface to provide moist heat therapy to reduce muscle spasms and cramps and/or joint and muscle stiffness and pain. It usually consists of a soft pad or a small pouch made of cotton, gauze, or linen available in a variety of thickness; it may also contain gel or absorbent materials. The device can be warmed in hot water or in a microwave oven. This is a reusable device.

Regulatory Flags#

DUNS number
656091279
Device count
1
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
true
Expiration date on label
false
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
00049696189583THERA Plus644101842026-06-09
00049696198189B.PURE644103382026-06-09
00049696295260THERA Plus644103662026-06-09
00049696295277THERA Plus644103662026-06-09
00049696295284THERA Plus644103662026-06-09
00049696295291THERA Plus644103662026-06-09
00049696295307THERA Plus644103662026-06-09
00049696295314THERA Plus644103662026-06-09
00049696508339THERA Plus64409658V2026-06-09
00049696508346B.PURE64409346B2026-06-09
00049696508360THERA Plus64409535A2026-06-09
00049696508377THERA Plus64409535B2026-06-09
00049696508384THERA Plus64409535C2026-06-09
00049696561228THERA Plus644103222026-06-09
00049696561518B.PURE644103252026-06-09
00049696562102B.PURE644103262026-06-09
00049696677547THERA Plus644103832026-06-09
00049696712194B.PURE644102892026-06-09
00049696898232B.PURE64410005D2026-06-09
00050428299838CVSHealth64408678AB2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04979844700116NEW MOXA STICKYAMASHO CO.,LTD.IMA2025-02-03
04979844930506MOGUSAN'S MOXA BOXYAMASHO CO.,LTD.IMA2025-02-03
04979844931008DEDICATED CARBONIZED MOXAYAMASHO CO.,LTD.IMA2025-02-03
04979844580015NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
04979844580039NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
16901452000178Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
06901452000171Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
14897076722454Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
14897076722546Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
06971175122368sunwin momShanghai Senwo Industry Co., Ltd.IMA2023-05-13
14897076721778Roll.Smoke.LSuzhou Shenlong Medical Apparatus Co., Ltd.IMA2023-04-07
00057475570446BIOS LivingThermor LtdIMA2023-03-31
10057475570443BIOS LivingThermor LtdIMA2023-03-31
08800018916537Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916544GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916551GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916568Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018914561DBC Moxa BurnerDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916411Tiger Warmer SmallDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916428Tiger Warmer LargeDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916435CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916442GuGwan Burning Bowl 1HoleDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916459GuGwan Burning Bowl 5HolesDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916510"""Moxa Shield """Dong Bang Medical co.,Ltd.IMA2023-01-15
18800018916534Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916541GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916558GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916565Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
28800018916432CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
06971175125567sunwin momShanghai Senwo Industry Co., Ltd.IMA2022-12-30