Chemo Mouthpiece

Primary DI
10860001416746
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUAIntraoral Cooling Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUAIntraoral Cooling DeviceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232917000Chemo MouthpieceChemo Mouthpiece, LLC2024-01-23QUA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860001416743PackageGS18In Commercial Distribution
30860001416740PackageGS12In Commercial Distribution
40860001416747PackageGS11In Commercial Distribution
50860001416744PackageGS125In Commercial Distribution
60860001416741PackageGS16In Commercial Distribution
10860001416715PreviousGS10
10860001416746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086000141674320860001416743
3086000141674030860001416740
4086000141674740860001416747
5086000141674450860001416744
6086000141674160860001416741
1086000141671510860001416715
1086000141674610860001416746

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.

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860001416753Chemo Mouthpiece100-10042024-05-23
20860001416743Chemo Mouthpiece100-00042024-05-23
20860001416750Chemo Mouthpiece100-10042024-05-23
10860001416715Chemo Mouthpiece100-00042024-05-22
10860001416722Denta-Cool100-00052024-05-22
10860001416739Chemo Mouthpiece100-10042024-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860001416753Chemo MouthpieceCHEMOMOUTHPIECE, LLCQUA2024-05-23
20860001416743Chemo MouthpieceCHEMOMOUTHPIECE, LLCQUA2024-05-23
20860001416750Chemo MouthpieceCHEMOMOUTHPIECE, LLCQUA2024-05-23