FDA UDI
In Commercial Distribution
🇺🇸 United States
Chemo Mouthpiece
DI: 10860001416746
·
Model: 100-0004
·
CHEMOMOUTHPIECE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
Basic Information
- Brand Name
- Chemo Mouthpiece
- Primary DI
- 10860001416746
- 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
- 2024-05-23
- Public Version
- 1
- Public Version Date
- 2024-05-31
- Public Version Status
- New
- Public Device Record Key
- 158d4483-6b4e-454c-814e-5eb066d13c41
Device Description
Intraoral Cryotherapy Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| QUA | Intraoral Cooling Device | Dental | 872.5590 | 2 |
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 |
|---|---|---|---|---|---|---|
| Package | 20860001416743 | GS1 | Box | 8 | In Commercial Distribution | |
| Primary | 10860001416746 | GS1 | ||||
| Package | 30860001416740 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 40860001416747 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 50860001416744 | GS1 | Box | 25 | In Commercial Distribution | |
| Previous | 10860001416715 | GS1 | ||||
| Package | 60860001416741 | GS1 | Box | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 866-496-8858
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232917 | 000 |