FDA UDI
In Commercial Distribution
🇺🇸 United States
NeXus-Q32
DI: 08719481550004
·
Model: 2.0
·
Mind Media Europe B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeXus-Q32
- Primary DI
- 08719481550004
- Version / Model
- 2.0
- Company Name
- Mind Media Europe B.V.
- Labeler DUNS
- 494765181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-19
- Public Version
- 4
- Public Version Date
- 2024-02-08
- Public Version Status
- Update
- Public Device Record Key
- 51dec3ab-a8a0-4ae1-90d3-2d7af1a8904d
Device Description
The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardless of any specific medical indication, by medical/research professionals.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32521 | Multiple physiological signal amplifier | An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719481550004 | GS1 |