Blood Volume Pulse Sensor (NC-BVP-H)

GUDID 08719481550066

NC-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 Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance Photometer, reflectance
Primary Device ID08719481550066
NIH Device Record Key4d574cdc-0c22-489a-a917-129b67f8595c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Volume Pulse Sensor (NC-BVP-H)
Version Model Number1.0
Company DUNS489837775
Company NameMind Media B.V.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108719481550066 [Primary]

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-27
Device Publish Date2021-07-19

Devices Manufactured by Mind Media B.V.

08719481550400 - NeXus-Q322023-02-16 The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardl
08719481550349 - NeXus-10 MKII2021-08-23 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-Q322021-07-27 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.