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
HCC Device, Biofeedback

GMDN Terms

Code Name
32521 Multiple physiological signal amplifier

Identifiers

Type ID
Primary 08719481550004