Home GUDID 20860001416743 Chemo Mouthpiece
Primary DI 20860001416743
Brand Chemo Mouthpiece
Company CHEMOMOUTHPIECE, LLC
Model 100-0004
Device description Intraoral Cryotherapy Device
Published 2024-05-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QUA Intraoral Cooling Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QUA Intraoral Cooling Device Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20860001416743 Package GS1 8 In Commercial Distribution 30860001416740 Package GS1 2 In Commercial Distribution 40860001416747 Package GS1 1 In Commercial Distribution 50860001416744 Package GS1 25 In Commercial Distribution 60860001416741 Package GS1 6 In Commercial Distribution 10860001416715 Previous GS1 0 10860001416746 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20860001416743 20860001416743 30860001416740 30860001416740 40860001416747 40860001416747 50860001416744 50860001416744 60860001416741 60860001416741 10860001416715 10860001416715 10860001416746 10860001416746
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 116840035 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10860001416746 Chemo Mouthpiece CHEMOMOUTHPIECE, LLC QUA 2024-05-23 10860001416753 Chemo Mouthpiece CHEMOMOUTHPIECE, LLC QUA 2024-05-23 20860001416750 Chemo Mouthpiece CHEMOMOUTHPIECE, LLC QUA 2024-05-23
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