Neuronaute Mobile Application Android

GUDID 03615220004294

BIOSERENITY MEDICAL DEVICES GROUP

Electroencephalographic monitoring system
Primary Device ID03615220004294
NIH Device Record Key776ae684-40eb-4144-b74a-e82792252e3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuronaute Mobile Application Android
Version Model Number5100-00024
Company DUNS281224773
Company NameBIOSERENITY MEDICAL DEVICES GROUP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103615220004294 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-28
Device Publish Date2024-02-20

Devices Manufactured by BIOSERENITY MEDICAL DEVICES GROUP

03615220003679 - Neuronaute Plus Touchproof Extender2024-05-30
03615220003983 - Neuronaute Plus- Holding Band2024-03-29
03615220003655 - Neuronaute Plus - DB25 Extender2024-02-28
03615220003662 - Neuronaute Plus- IceCap Extender2024-02-28
03615220003990 - Neuronaute Plus - Core Module 2024-02-28
03615220004294 - Neuronaute Mobile Application Android2024-02-28
03615220004294 - Neuronaute Mobile Application Android2024-02-28
03615220001026 - Cardioskin Textile S202023-12-28
03615220001033 - Cardioskin Textile S222023-12-28

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