FDA.reportPublic FDA data

BeKoool

Primary DI
00667560002006
Brand
BeKoool
Company
KOBAYASHI CONSUMER PRODUCTS, LLC
Model
667560002006
Device description
Cooling Gel Sheets Migraine
Published
2020-07-01
Public version status
New
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
10667560002003PackageGS124In Commercial Distribution
00667560002006PrimaryGS10
60667560002008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066756000200310667560002003
00667560002006006675600020066675600020060667560002006
6066756000200860667560002008

GMDN Terms#

Term, Definition table
TermDefinition
Cold/cool therapy gelA non-sterile, jelly-like substance in a container or in patch/strip form intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries or to reduce pain from tension headache/migraine (cold therapy), and/or for cooling at the skin surface to treat heat rash or sooth irritation (cool therapy). After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)432-6329kcpinfo@kobayashi.com

Regulatory Flags#

DUNS number
618672760
Device count
4
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667560800138HotHands Therapy6675608001382023-12-01
10667560800135HotHands Therapy6675608001382023-12-01
00667560001009BeKoool6675600010092020-07-01
00667560060471Beyond Sleep6675600604712020-07-01
00667560060501BeKoool6675600605012020-07-01
00667560060563BeKoool6675600605632021-01-26
10667560060560BeKoool6675600605632021-01-26
00667560011008Cura Heat6675600110082020-09-01
00667560011039Cura Heat6675600110392020-09-01
10667560011005Cura Heat6675600110082020-09-01
10667560011036Cura Heat6675600110392020-09-01
00667560005007BeKoool6675600050072020-07-01
00667560060518BeKoool6675600605182020-07-01
10067560001004BeKoool6675600010092020-07-01
10667560002003BeKoool6675600020062020-07-01
10667560005004BeKoool6675600050072020-07-01
10667560060478Beyond Sleep6675600604712020-07-01
10667560060508BeKoool6675600605012020-07-01
10667560060515BeKoool6675600605182020-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08436587171017ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171031ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171208ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171253ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171284ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171314ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171338ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171352ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171505ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171666ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15