FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearUP Sinus Relief Pain
DI: 00850006251001
·
Model: SN100
·
TIVIC HEALTH SYSTEMS INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearUP Sinus Relief Pain
- Primary DI
- 00850006251001
- Version / Model
- SN100
- Catalog Number
- SN100
- Company Name
- TIVIC HEALTH SYSTEMS INC.
- Labeler DUNS
- 080598314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-14
- Public Version
- 2
- Public Version Date
- 2021-03-18
- Public Version Status
- Update
- Public Device Record Key
- 68878fa3-6b2a-4f76-91b0-21d171a1001c
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
| QNU | Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion | Ear, Nose, Throat | 874.6000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60682 | Craniofacial analgesia electrical stimulator | A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850006251001 | GS1 |