FDA.reportPublic FDA data

Magic gel

Primary DI
06975306622062
Brand
Magic gel
Company
Anhui Kamt Ice Pack Co.,Ltd.
Model
Gloveicepack2pk
Published
2022-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYRBag, Ice

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYRBag, IceGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975306622062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975306622062069753066220626975306622062

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
406640752
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
06975306620013Magic gelMigraineicepack00042022-10-25
06975306620020magicgelPurplemigrainegelcap2022-10-25
06975306620037magicgelHorseicepack2022-10-25
06975306620044magicgelblackmigrainegelpack2022-10-25
06975306620051magicgelMigraineicepack2PK2022-10-25
06975306620068magicgelHorseicepack2PK2022-10-25
06975306622024Magic gelHipicepack00042022-10-25
06975306622031Magic gelfemalegelpack2022-10-25
06975306622048Magic gelshinicepack2022-10-25
06975306622055Magic gelGloveicepack2022-10-25
06975306623014magicgelHemgelpack2022-10-25
06975306624011magicgelfacegelpack2022-10-25
06975306624028magicgelfingericepack2022-10-25
06975306625018magicgelHEATEYEMASK2022-10-25
06975306626015magicgellonglastingicepack2022-10-25
06975306627012magicgelEblackmigrainegelcap2022-10-25
06975306622017Magic gelShouldericepack00042022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612606001642KERMACardinal Health 200, LLCKYR2026-01-29
10612606001649KERMACardinal Health 200, LLCKYR2026-01-29
00885914108062Sammons Preston Performance Health Supply, LLCKYR2026-01-23
00885914108079Sammons PrestonPerformance Health Supply, LLCKYR2026-01-23
10860001416715Chemo MouthpieceCHEMOMOUTHPIECE, LLCKYR2024-05-22
10860001416722Denta-CoolCHEMOMOUTHPIECE, LLCKYR2024-05-22
10860001416739Chemo MouthpieceCHEMOMOUTHPIECE, LLCKYR2024-05-22
00683534040010A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040027A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040034A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040016A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040023A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040030A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
M20890046941CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046951CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046942CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046952CUSTOMEDCUSTOMED INCKYR2023-08-10
00810132040061HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00810132040078HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040068HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040075HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00057475570095BIOS LivingThermor LtdKYR2023-03-31
10057475570092BIOS LivingThermor LtdKYR2023-03-31
00049696507806THERA PlusFOURSTAR GROUP INC.KYR2023-02-05
06975306620013Magic gelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620020magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620037magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620044magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620051magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620068magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25