Bioserenity Cloud

GUDID 03615220004270

Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals.

BIOSERENITY

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Primary Device ID03615220004270
NIH Device Record Keya5f788d4-96ff-4c03-b4fe-c63bf33b503f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioserenity Cloud
Version Model Number1012-21002-US
Company DUNS265828238
Company NameBIOSERENITY
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
GS103615220004270 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-08-29
Device Publish Date2021-02-15

On-Brand Devices [Bioserenity Cloud]

036152200025733.3.0
03615220004270Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recor

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