Cura Heat

Basic Information

• Brand Name: Cura Heat
• Primary DI: 00667560011008
• Version / Model: 667560011008
• Company Name: KOBAYASHI CONSUMER PRODUCTS, LLC
• Labeler DUNS: 618672760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-09-01
• Public Version: 1
• Public Version Date: 2020-09-09
• Public Version Status: New
• Public Device Record Key: 2237b0a6-3b10-4505-8ae0-bdd955adcf75

Device Description

Heat Therapy Patches

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: Yes
• 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
37697	Exothermic heat therapy pack/patch	A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10667560011005	GS1	box	24	In Commercial Distribution
Primary	00667560011008	GS1
Unit of Use	60667560011000	GS1

Customer Contacts

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