FDA.reportPublic FDA data

BeKoool

Primary DI
10067560001004
Brand
BeKoool
Company
KOBAYASHI CONSUMER PRODUCTS, LLC
Model
667560001009
Device description
Cooling Gel Sheets Fever
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10067560001004PackageGS124In Commercial Distribution
00667560001009PrimaryGS10
60067560001009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1006756000100410067560001004
00667560001009006675600010096675600010090667560001009
6006756000100960067560001009

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
618672760
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00667560002006BeKoool6675600020062020-07-01
00667560005007BeKoool6675600050072020-07-01
00667560060518BeKoool6675600605182020-07-01
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