NeXus Software

Primary DI
08719481550332
Brand
NeXus Software
Company
Mind Media Europe B.V.
Model
1.0.204.6
Device description
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Published
2021-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719481550332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719481550332087194815503328719481550332

GMDN Terms#

Term, Definition table
TermDefinition
Biofeedback system application softwareAn application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
494765181
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719481550165NeXus Q241.02025-12-03
08719481550110NeXus 10 MK31.02025-09-10
08719481550400NeXus-Q323.02023-02-08
08719481550349NeXus-10 MKII1.22021-08-13
08719481550080Temperature Sensor (NB-TMP)1.02021-07-19
08719481550097GSR-TMP Combination Sensor (NC-C-GT)1.02021-07-19
08719481550004NeXus-Q322.02021-07-19
08719481550035Blood Volume Pulse Sensor (NB-BVP-F)1.02021-07-19
08719481550042Blood Volume Pulse Sensor (NB-BVP-H)1.02021-07-19
08719481550059Blood Volume Pulse Sensor (NC-BVP-F)1.02021-07-19
08719481550066Blood Volume Pulse Sensor (NC-BVP-H)1.02021-07-19
08719481550073Galvanic Skin Response Sensor (NB-GSR)1.02021-07-19

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