Blood Volume Pulse Sensor (NB-BVP-H)

GUDID 08719481550042

NB-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media B.V.

Photometer, reflectance

• Primary Device ID: 08719481550042
• NIH Device Record Key: 5355b39e-51d8-42ef-a706-652bac754abd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Volume Pulse Sensor (NB-BVP-H)
• Version Model Number: 1.0
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719481550042 [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): 2021-07-27NB-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
• 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