NeXus-10 MKII

GUDID 08719481550349

The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications. The NeXus 10 MKII is intended for use on humans. The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.

Mind Media B.V.

Multiple physiological signal amplifier

• Primary Device ID: 08719481550349
• NIH Device Record Key: 6c28a146-c34d-45df-a717-415a08e72c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeXus-10 MKII
• Version Model Number: 1.2
• Company DUNS: 489837775
• Company Name: Mind Media B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	08719481550349 [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: 2021-08-23
• Device Publish Date: 2021-08-13

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: 2021-08-23The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications. The NeXus 10 MKII is intended for use on humans. The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.
• 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