HotHands Therapy

Basic Information

• Brand Name: HotHands Therapy
• Primary DI: 00667560800138
• Version / Model: 667560800138
• Company Name: KOBAYASHI CONSUMER PRODUCTS, LLC
• Labeler DUNS: 618672760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: 64cc3756-e710-4ed0-a72f-3cea07d15ce9

Device Description

Warming Earplugs

Device Characteristics

• Single Use: No
• 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
EWD	Protector, Hearing (Insert)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
41230	Earplugs, reusable	A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10667560800135	GS1	box	24	In Commercial Distribution
Primary	00667560800138	GS1
Package	10667560800203	GS1	box	6	In Commercial Distribution

Customer Contacts

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