AccessGUDID - DEVICE: Bioserenity Cloud (03615220004270)

GUDID

Device Identifier (DI) Information

Brand Name: Bioserenity Cloud
Version or Model: 1012-21002-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOSERENITY MEDICAL DEVICES GROUP

Primary DI Number: 03615220004270
Issuing Agency: GS1
Commercial Distribution End Date: January 21, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 281224773 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46564	Bio-energy preliminary diagnosis system application software	An individual software program or group of programs, routines and/or algorithms, that add specific image processing and/or analysis capabilities to a computer for storing, processing, managing and displaying electronic information/data used to interpret preliminary diagnostic parameters derived from biological active zones (BAZ). It is typically for installation in an off-the-shelf desktop or laptop computer. Data from the impulses picked up by the sensor devices are processed by the software and assimilated with a knowledge management infrastructure that assists in producing the on-screen data and analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5f788d4-96ff-4c03-b4fe-c63bf33b503f
Public Version Date: January 23, 2025
Public Version Number: 6
DI Record Publish Date: February 15, 2021