FDA.reportPublic FDA data

Walgreens

Primary DI
00311917069159
Brand
Walgreens
Company
WALGREEN CO.
Model
838102
Device description
Walgreens Cold Therapy System
Published
2025-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10311917069156PackageGS11In Commercial Distribution
00311917069159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031191706915610311917069156
00311917069159003119170691593119170691590311917069159

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system pack, reusableA device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-925-4733consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08
00311917085753Walgreens7208922026-05-08
00311917085760Walgreens7208972026-05-08
00311917077598Walgreens7377342026-04-28
00311917151434Walgreens2205442019-11-29
00311917151472Walgreens2205502019-11-28
00311917219288Walgreens2729422020-11-26
00311917219295Walgreens2729432020-11-26
00311917064635Walgreens351587 2025-06-20
00311917006239Walgreens2964622023-01-25
00311917065724Walgreens8246332025-04-29
00311917065731Walgreens8246322025-04-29
00311917065762WALGREENS8416972025-04-29
00311917065779WALGREENS7456072025-04-29
00311917066585WALGREENS8360682025-04-29
00311917199603WALGREENS8281472022-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644021CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-12
00812120001412Game Ready Articulated Knee Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001429Game Ready Right Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001535Game Ready Straigh Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001580Game Ready Shoulder Wrap - Medium - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001597Game Ready Shoulder Wrap - Medium - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001603Game Ready Shoulder Wrap - Large - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001634Game Ready C-T Spine Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001658Game Ready Hip/Groin Wrap - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001672Game Ready Flexed Elbow Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120002662Game Ready Med4 Elite Drain HoseAvanos Medical, Inc.ILO2023-04-05
08809802643260CTC-7DAESUNG MAREF CO.,LTD.ILO2022-05-09
00810041988126ViveVIVE HEALTH LLCILO2021-11-30
00810041988133Vive VIVE HEALTH LLCILO2021-11-30