Neuronaute IceCap 2 Small

GUDID 03615220003792

IceCap 2 is a medical device used as EEG electrodes. It is used by Healthcare Professionals on a patient in case of neurological disorders diagnostic with a long-term EEG record. IceCap 2 shall be placed on patients weighing at least 10 kg and having a head circumference above 43 cm

BIOSERENITY MEDICAL DEVICES GROUP

Electroencephalographic electrode cap, single-use
Primary Device ID03615220003792
NIH Device Record Keyef1fe661-bcdc-46ba-8ffe-b8a1fb662447
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuronaute IceCap 2 Small
Version Model Number1001-01015-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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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 HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103615220003792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

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 Date2023-01-25

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