FDA.reportPublic FDA data

Chemo Mouthpiece

Primary DI
10860001416715
Brand
Chemo Mouthpiece
Company
CHEMOMOUTHPIECE, LLC
Model
100-0004
Device description
Intraoral Cryotherapy Device
Published
2024-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYRBag, Ice

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYRBag, IceGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860001416712PackageGS18In Commercial Distribution
30860001416719PackageGS12In Commercial Distribution
40860001416716PackageGS12In Commercial Distribution
50860001416713PackageGS11In Commercial Distribution
10860001416715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086000141671220860001416712
3086000141671930860001416719
4086000141671640860001416716
5086000141671350860001416713
1086000141671510860001416715

GMDN Terms#

Term, Definition table
TermDefinition
Oral mucositis cryotherapy mouthpieceA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-496-8858support@chemomouthpiece.com

Regulatory Flags#

DUNS number
116840035
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860001416746Chemo Mouthpiece100-00042024-05-23
10860001416753Chemo Mouthpiece100-10042024-05-23
20860001416743Chemo Mouthpiece100-00042024-05-23
20860001416750Chemo Mouthpiece100-10042024-05-23
10860001416722Denta-Cool100-00052024-05-22
10860001416739Chemo Mouthpiece100-10042024-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612606001642KERMACardinal Health 200, LLCKYR2026-01-29
10612606001649KERMACardinal Health 200, LLCKYR2026-01-29
00885914108062Sammons Preston Performance Health Supply, LLCKYR2026-01-23
00885914108079Sammons PrestonPerformance Health Supply, LLCKYR2026-01-23
10860001416722Denta-CoolCHEMOMOUTHPIECE, LLCKYR2024-05-22
10860001416739Chemo MouthpieceCHEMOMOUTHPIECE, LLCKYR2024-05-22
00683534040010A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040027A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040034A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040016A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040023A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040030A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
M20890046941CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046951CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046942CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046952CUSTOMEDCUSTOMED INCKYR2023-08-10
00810132040061HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00810132040078HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040068HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040075HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00057475570095BIOS LivingThermor LtdKYR2023-03-31
10057475570092BIOS LivingThermor LtdKYR2023-03-31
00049696507806THERA PlusFOURSTAR GROUP INC.KYR2023-02-05
06975306620013Magic gelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620020magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620037magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620044magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620051magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620068magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306622024Magic gelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25