Nurochek-Pro HS03-369

GUDID 09357225000034

Evoked-potential graphic recording system

Primary Device ID	09357225000034
NIH Device Record Key	c19ba426-9bc3-4645-8ee1-d825e4f13129
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nurochek-Pro
Version Model Number	Nurochek-Pro Kit (HS03-369) rev 1
Catalog Number	HS03-369
Company DUNS	748905226
Company Name	HEADSAFE MFG PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
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

Storage Environment Atmospheric Pressure	Between 620 millibar and 1060 millibar
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 620 millibar and 1060 millibar
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 620 millibar and 1060 millibar
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 620 millibar and 1060 millibar
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 620 millibar and 1060 millibar
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Issuing Agency	Device ID
GS1	09357225000034 [Primary]

OMC	Reduced- Montage Standard Electroencephalograph

Steralize Prior To Use	false
Device Is Sterile	false

09357225000034 - Nurochek-Pro	2025-12-23The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment of brain function. The system comprises a wearable EEG headset, associated sensors and accessories, and supporting software components. The device is intended for use by healthcare professionals in clinical environments. The kit is supplied as a complete system configuration and is not sterile.
09357225000034 - Nurochek-Pro	2025-12-23 The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment of brain function. The system co
09357225001017 - Nurochek-Pro Headset	2025-12-23 The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potenti
09357225002021 - Nurochek-Pro Application	2025-12-23 The Nurochek-Pro Application (app) Software is a Windows desktop application that acts as the primary graphical user interface (
09357225002038 - Nurochek-Pro Server	2025-12-23 The Nurochek-Pro Server is an umbrella term for backend software of the Nurochek-Pro System (HS03-369). It provides the function
09357225003028 - Nurochek-Pro Soft Sensor Kit	2025-12-23 The Nurochek-Pro Soft Sensor Kit is a non-invasive accessory intended for use with the Nurochek-Pro headset. The kit contains so
09357225006029 - Nurochek-Pro Saline Solution	2025-12-23 The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The so