Chemo Mouthpiece

Basic Information

• Brand Name: Chemo Mouthpiece
• Primary DI: 10860001416715
• Version / Model: 100-0004
• Company Name: CHEMOMOUTHPIECE, LLC
• Labeler DUNS: 116840035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-22
• Public Version: 1
• Public Version Date: 2024-05-30
• Public Version Status: New
• Public Device Record Key: 63122930-c2b0-4738-b82d-554d433db3ec

Device Description

Intraoral Cryotherapy Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
KYR	Bag, Ice	General Hospital	880.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64345	Oral mucositis cryotherapy mouthpiece	A non-powered device intended to be used during a chemotherapy treatment session for the application of cold/freezing temperatures to the oral cavity to help prevent and/or reduce symptoms associated with oral mucositis caused by chemotherapy (e.g., swelling, pain, mouth sores, bleeding gums). It is designed to be chilled in a freezer prior to use, and is in the form of a synthetic polymer mouthguard placed in front of the teeth with an external chamber containing water designed to be periodically squeezed by the patient to circulate cold water through the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10860001416715	GS1
Package	20860001416712	GS1	Box	8	In Commercial Distribution
Package	30860001416719	GS1	Box	2	In Commercial Distribution
Package	40860001416716	GS1	Box	2	In Commercial Distribution
Package	50860001416713	GS1	Box	1	In Commercial Distribution

Customer Contacts

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