FDA UDI
In Commercial Distribution
🇺🇸 United States
Q-Sense CPM Thermal Sensory Analazer
DI: 07290103039257
·
Model: Q-Sense CPM
·
MEDOC LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Q-Sense CPM Thermal Sensory Analazer
- Primary DI
- 07290103039257
- Version / Model
- Q-Sense CPM
- Catalog Number
- MO 00013-CPM
- 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
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 259ff125-a5ba-4143-b16c-5cb338db11c3
Device Description
The Q-Sense CPM Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and advance research in the field of Pain Management. The CPM Model offers additional capabilities to the Q-Sense device including: Simultaneous operation of two Thermodes, Ramp & Hold method, Computerized Visual Analog Scale (CoVAS). The Device includes: main unit, two thermodes and accessories.
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
- 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 |
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 | 07290103039257 | GS1 | ||||
| Package | 07290103039752 | GS1 | Carton | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +97249038800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922052 | 000 |