BeKoool

Basic Information

• Brand Name: BeKoool
• Primary DI: 00667560001009
• Version / Model: 667560001009
• Company Name: KOBAYASHI CONSUMER PRODUCTS, LLC
• Labeler DUNS: 618672760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2020-07-01
• Public Version: 2
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: d9dd26a8-f2de-475f-a2d5-96d3a0fda346

Device Description

Cooling Gel Sheets Fever

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMD	PACK, HOT OR COLD, DISPOSABLE	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46556	Cold/cool therapy gel	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10067560001004	GS1	box	24	In Commercial Distribution
Primary	00667560001009	GS1
Unit of Use	60067560001009	GS1
Package	10667560060409	GS1	box	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]