FDA.reportPublic FDA data

Meijer Hot & Cold Compression Migraine Mask

Primary DI
00719283338334
Brand
Meijer Hot & Cold Compression Migraine Mask
Company
MEIJER, INC.
Model
719283338334
Device description
Meijer Hot & Cold Compression Migraine Mask
Published
2024-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00719283338334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00719283338334007192833383347192833383340719283338334

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA 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) 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006959555
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713733712835MeijerMJ4035V1MJ4035V12026-06-05
00719283515964meijer71928351596443238042019-07-30
00713733293129MEIJERMJFAK150V2MJFAK150V22026-04-20
00760236195603MeijerMJFAKMINIMJFAKMINI2026-04-20
00760236195771Meijer20002290N/A2026-04-01
00760236195818Meijer20002291N/A2026-04-01
00760236264811Meijer Advanced One Step Pregnancy Test2020-10-02
00760236264828Meijer Advanced Early Result Pregnancy Test2020-10-02
00760236471646Meijer Saline Wound Wash 95-50740-200-002026-03-06
00719283501233Meijer74-9713487072020-12-07
00719283501288Meijer74-9732020-12-07
00708820957367Meijer, instant cold pack, value pack 36501102021-02-04
00708820957473Meijer, instant cold pack 36501092020-07-21
00708820519541Meijer Hot/Cold Back Pad34572442017-08-01
00708820519558Meijer Hot & Cold Wrap Ultra-Forming 34572462017-08-01
00708820523418Meijer Hot & Cold Therapy Wrap with Clay Based Technology34583982017-08-01
00708820523425Meijer Hot & Cold Beads Compress with Strap34583972017-08-01
00708820523432Meijer Moist Heat Neck Wrap34583962017-08-01
00760236195696Meijer57005082025-12-24
00760236195702Meijer57005242025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00840397513215Sharper ImageMerchsource, LLCIME2026-04-23
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18
00197998026133Solventum™Solventum US LLCIME2026-02-15
00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.IME2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
00810113683638Cold Compression Wrap, Pro-Ankle WrapManamed, Inc.IME2025-09-26
00810113683645Cold Compression Wrap, Pro-Back WrapManamed, Inc.IME2025-09-26
00810113683652Cold Compression Wrap, Pro-Elbow WrapManamed, Inc.IME2025-09-26
00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.IME2025-09-26
00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.IME2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
00850073571101American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00850073571118American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040056Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040063Pain CakesDrive Devilbiss HealthcareIME2025-06-03