FDA.reportPublic FDA data

JMU

Primary DI
00840456203828
Brand
JMU
Company
JMU DENTAL, INC
Model
25001002
Device description
"Instant Cold Pack, 6"" x 9"", 24pcs/box, 2 boxes/case"
Published
2025-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00840456203828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456203828008404562038288404562038280840456203828

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, single-useA non-sterile 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, peat) 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081258380
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456225424JMU368150012026-10-14
00840456225431JMU368150022026-10-14
00840456225332JMU369430022026-10-13
00840456225349JMU369430032026-10-13
00840456225394JMU463070032026-10-13
00840456225400JMU361020042026-10-13
00840456225417JMU361020052026-10-13
00840456225271JMU520210022026-10-12
00840456224656JMU229080452026-10-09
00840456224663JMU229080462026-10-09
00840456224670JMU229080472026-10-09
00840456224687JMU229080482026-10-09
00840456224694JMU229080492026-10-09
00840456224700JMU229080502026-10-09
00840456224717JMU229080512026-10-09
00840456224724JMU229080522026-10-09
00840456224731JMU229080532026-10-09
00840456225264JMU520210012026-10-09
00840456224861JMU410122532026-09-30
00840456224878JMU410122542026-09-30

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