FDA.reportPublic FDA data

Munchkin

Primary DI
10735282287845
Brand
Munchkin
Company
MUNCHKIN, INC.
Model
MKCA0999 Rev 1
Published
2026-03-18
Public version status
New
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
10735282287845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1073528228784510735282287845

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.

Regulatory Flags#

DUNS number
787026855
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
00735282213182TheraBurpee Reusable Hot & Cold Gel Packs - 2pk213182021-10-01
00735282286810MunchkinMKFE0964 Rev 1286812025-02-12
10735282286817MunchkinMKFE0964 Rev 1286812025-02-12
00735282281310MunchkinMKFE0951 Rev 2281312024-11-14
00735282281327MunchkinMKFE0952 Rev 2281322024-11-14
00735282281334MunchkinMKFE0951 Rev 1281332024-11-14
00735282281358MunchkinMKFE0952 Rev 1281352024-11-14
10735282281317MunchkinMKFE0951 Rev 2281312024-11-14
10735282281324MunchkinMKFE0952 Rev 2281322024-11-14
10735282281331MunchkinMKFE0951 Rev 1281332024-11-14
10735282281355MunchkinMKFE0952 Rev 1281352024-11-14
00735282381843MunchkinMKFE0927 Rev 1381842024-08-01
00735282381850MunchkinMKFE0923 Rev 1381852024-08-01
00735282383946MunchkinMKFE0927 Rev 1383942024-08-01
10735282381840MunchkinMKFE0927 Rev 1381842024-08-01
10735282381857MunchkinMKFE0923 Rev 1381852024-08-01
10735282383943MunchkinMKFE0927 Rev 1383942024-08-01
00735282383236MunchkinMKFE0924 Rev 1383232024-06-25
00735282383243MunchkinMKFE0924 Rev 2383242024-06-25
00735282383984MunchkinMKFE0925 Rev 1383982024-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
00840397513215Sharper ImageMerchsource, LLCIME2026-04-23
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
00197998026133Solventum™Solventum US LLCIME2026-02-15
00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178881840Arctic FlexVIVE HEALTH LLCIME2026-02-05
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
00810178880300Arctic FlexVIVE HEALTH LLCIME2025-04-04