FDA UDI
In Commercial Distribution
🇺🇸 United States
Component Neuromonitoring System
DI: B485CNSEEG2001
·
Model: CNS-EEG-200
·
MOBERG RESEARCH INC
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Component Neuromonitoring System
- Primary DI
- B485CNSEEG2001
- Version / Model
- CNS-EEG-200
- Company Name
- MOBERG RESEARCH INC
- Labeler DUNS
- 029957656
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-21
- Public Version
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 55586eb6-a3d0-43c5-adfb-1284bd1e4e6f
Device Description
Optional 16 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.
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
- 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 |
|---|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
| ORT | Burst Suppression Detection Software For Electroencephalograph | Neurology | 882.1400 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
| OMA | Amplitude-Integrated Electroencephalograph | Neurology | 882.1400 | 2 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | 882.1400 | 2 |
| MUD | Oximeter, Tissue Saturation | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36740 | Electroencephalographic signal amplifier | An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B485CNSEEG2001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080217 | 000 |