Neuronaute 1.2 - High capacity battery module

GUDID 03615220001729

The Neuronaute Battery High Capacity module is a removable, rechargeable electronic device. The battery is recharged using a charging station. It connects to the Neuronaute BioAdapter using 3 snap buttons located on its rear.

BIOSERENITY MEDICAL DEVICES GROUP

Electroencephalographic monitoring system
Primary Device ID03615220001729
NIH Device Record Keyd7384a71-c849-4b5c-87a9-9c0625ad275f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuronaute 1.2 - High capacity battery module
Version Model Number1001-15016-UN
Company DUNS281224773
Company NameBIOSERENITY MEDICAL DEVICES GROUP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103615220001729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-12-28
Device Publish Date2023-01-12

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