FDA UDI
In Commercial Distribution
🇺🇸 United States
Contact Heat Evoked Potential Stimulator
DI: 07290103039318
·
Model: CHEPS
·
MEDOC LTD.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Contact Heat Evoked Potential Stimulator
- Primary DI
- 07290103039318
- Version / Model
- CHEPS
- Company Name
- MEDOC LTD.
- Labeler DUNS
- 600469191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 85abe8b1-cd6e-4b46-97d4-82d1e23e56c6
Device Description
The Modified Contact Heat Evoked Potential Stimulator (CHEPS) is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as stimulator for creating sensation and pain stimuli in the sensory nerves fibers. the CHEPS indicated for the use in evaluating the functionality of human reception and transmission of sensory pathways The Device includes: main electrical unit, external cooling unit, at least one thermode probe and accessories.
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LQW | Test, Temperature Discrimination | Neurology | 882.1200 | 1 |
| NTU | Evoked Potential Stimulator, Thermal | Neurology | 882.1870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37350 | Thermotester, diagnostic | A mains electricity (AC-powered) device designed to provide quantitative diagnostic evaluation of a patient's reaction to thermal stimuli, typically on the skin surface, by providing information on threshold to heat or cold perception. The device typically operates by gradually increasing the temperature to 42 - 50? Celsius. It is typically used to diagnose early diabetes mellitus, for phantom pain detection, neurological studies of thin fibre nerve systems, and also for pain threshold investigations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290103039318 | GS1 |