FDA.reportPublic FDA data

Curad

Primary DI
00080196778631
Brand
Curad
Company
MEDLINE INDUSTRIES, INC.
Model
CUR961R
Catalog number
CUR961R
Device description
COLD PACK,INSTANT,CURAD,2/BX,24CS
Published
2021-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
40080196282167PackageGS16In Commercial Distribution
40080196493075PackageGS14In Commercial Distribution
00080196778631PrimaryGS10
80080196778637Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4008019628216740080196282167
4008019649307540080196493075
00080196778631000801967786310801967786310080196778631
8008019677863780080196778637

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, reusableA non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from extreme heat and open flame. Protect from freezing.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
2
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344235391MEDLINEMPHEPREEMIEMPHEPREEMIE2026-10-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10884389112090MEDLINEEQX7012EQX70122026-10-09
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10884389931967MEDLINEMSC7366EPMSC7366EP2026-10-09
20193489079804MEDLINEBNS128632BNS1286322026-10-09
30193489079726MEDLINEBNS111718BNS1117182026-10-09
30193489079771MEDLINEBNS119386BNS1193862026-10-09
30193489079788MEDLINEBNS119387BNS1193872026-10-09
30193489079795MEDLINEBNS120988BNS1209882026-10-09
10197344104116MEDLINEPIVBCA18125PIVBCA181252025-02-06
10197344104130MEDLINEPIVBCA20100PIVBCA201002025-02-06
10197344104147MEDLINEPIVBCA20125PIVBCA201252025-02-06
20197344024992MedlineMPH22325HCGMPH22325HCG2024-03-11
10197344042388HUDSON RCIHUD1895HUD18952026-10-08
10197344042395HUDSON RCIHUD1896HUD18962026-10-08
10653160394273MEDLINEDYND71006DYND710062026-10-08
10653160394532MEDLINEDT22100ADT22100A2026-10-08
10653160394594MEDLINEDYNDC3490ADYNDC3490A2026-10-08
10653160394709MEDLINEDYNDC3601DYNDC36012026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841445001425Diva Hot Flash PatchDiva International IncIMD2026-10-12
00841445001432Diva Hot Flash PatchDiva International IncIMD2026-10-12
00841445001449Diva Hot Flash PatchDiva International IncIMD2026-10-12
06941917859852HuayilangShandong Zhushi Pharmaceutical Group Co., Ltd. First OfficeIMD2026-10-11
00845819082003Oasis REST & RELIEF Single-UseOASIS MEDICAL, INC.IMD2026-08-14
00845819083000Oasis REST & RELIEF Plus Single-UseOASIS MEDICAL, INC.IMD2026-08-14
10080196158652MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.IMD2026-07-16
00808829131321Lucky Super SoftDELTA BRANDS INC.IMD2026-07-10
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170362ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170386ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170553ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170560ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170638ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170812ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15