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
00311917034218Walgreens7654302023-07-11
00311917034249Walgreens7654262023-07-11
00311917077932Walgreens7394332026-10-14
00311917090498Walgreens4172342026-10-12
00311917088556Walgreens3119170885562026-09-30
00311917086521Walgreens1439332026-09-28
00311917156064WALGREENS2576322020-07-22
00311917080062Walgreens7610162026-08-26
00311917086569Walgreens1666772026-08-21
00311917086590Walgreens1666372026-08-21
00311917122045Walgreens5052882023-03-09
00311917158952Walgreens276743WRX2767432020-07-14
00311917014876Walgreens6772599288502016-12-20
00311917048130Walgreens6548789288562016-12-20
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.ILO2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.ILO2026-10-12
00749756401678DeRoyalDEROYAL INDUSTRIES, INC.ILO2026-09-18
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.ILO2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.ILO2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.ILO2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.ILO2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.ILO2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.ILO2026-07-31