HotHands Therapy

GUDID 10667560800135

Warming Earplugs

KOBAYASHI CONSUMER PRODUCTS, LLC

Earplugs, reusable

• Primary Device ID: 10667560800135
• NIH Device Record Key: 64cc3756-e710-4ed0-a72f-3cea07d15ce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HotHands Therapy
• Version Model Number: 667560800138
• Company DUNS: 618672760
• Company Name: KOBAYASHI CONSUMER PRODUCTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com
• Phone: 1(800)432-6329
• Email: kcpinfo@kobayashi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667560800138 [Primary]
GS1	10667560800135 [Package]; Contains: 00667560800138; Package: box [24 Units]; In Commercial Distribution
GS1	10667560800203 [Package]; Package: box [6 Units]; In Commercial Distribution

FDA Product Code

• EWD: Protector, Hearing (Insert)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-11
• Device Publish Date: 2023-12-01

Devices Manufactured by KOBAYASHI CONSUMER PRODUCTS, LLC

• 10667560800135 - HotHands Therapy: 2023-12-11Warming Earplugs
• 10667560800135 - HotHands Therapy: 2023-12-11 Warming Earplugs
• 10667560060560 - BeKoool: 2021-02-03 Cooling Gel Sheets Mint
• 10667560011005 - Cura Heat: 2020-09-09 Heat Therapy Patches
• 10667560011036 - Cura Heat: 2020-09-09 Heat Therapy Patches
• 10067560001004 - BeKoool: 2020-07-09 Cooling Gel Sheets Fever
• 10667560002003 - BeKoool: 2020-07-09 Cooling Gel Sheets Migraine
• 10667560005004 - BeKoool: 2020-07-09 Cooling Gel Sheets Migraine
• 10667560060478 - Beyond Sleep: 2020-07-09 Anti-Snoring Strips