Bioserenity Cloud 1012-21002-US

GUDID 03615220002573

BIOSERENITY

Bio-energy preliminary diagnosis system application software

• Primary Device ID: 03615220002573
• NIH Device Record Key: a5f788d4-96ff-4c03-b4fe-c63bf33b503f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioserenity Cloud
• Version Model Number: 3.3.0
• Catalog Number: 1012-21002-US
• Company DUNS: 265828238
• Company Name: BIOSERENITY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615220002573 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [Bioserenity Cloud]

• 03615220002573: 3.3.0
• 03615220004270: Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recor