NeXus Software

GUDID 08719481550332

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.

Mind Media B.V.

Biofeedback system application software

• Primary Device ID: 08719481550332
• NIH Device Record Key: 57893179-42be-46b2-adb8-766d6384beb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeXus Software
• Version Model Number: 1.0.204.6
• Company DUNS: 489837775
• Company Name: Mind Media B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719481550332 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

Devices Manufactured by Mind Media B.V.

• 08719481550400 - NeXus-Q32: 2023-02-16 The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardl
• 08719481550349 - NeXus-10 MKII: 2021-08-23 The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-phy
• 08719481550080 - Temperature Sensor (NB-TMP): 2021-07-27 NB-TMP: The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connecte
• 08719481550097 - GSR-TMP Combination Sensor (NC-C-GT): 2021-07-27 NC-C-GT: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition d
• 08719481550004 - NeXus-Q32: 2021-07-27 The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardl
• 08719481550035 - Blood Volume Pulse Sensor (NB-BVP-F): 2021-07-27 NB-BVP-F (finger module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisiti
• 08719481550042 - Blood Volume Pulse Sensor (NB-BVP-H): 2021-07-27 NB-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition
• 08719481550059 - Blood Volume Pulse Sensor (NC-BVP-F): 2021-07-27 NC-BVP-F (finger module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisiti