BioSerenity-Link

GUDID 03615220003785

BioSerenity-Link is a mobile application capable of sharing phone connectivity, recording video and uploading it to the BioSerenity Cloud

BIOSERENITY MEDICAL DEVICES GROUP

Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software

• Primary Device ID: 03615220003785
• NIH Device Record Key: 61f71c26-b43a-4121-bb65-1cb40140abc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSerenity-Link
• Version Model Number: 5100-00021-UN
• Company DUNS: 281224773
• Company Name: BIOSERENITY MEDICAL DEVICES GROUP
• 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: true
• 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	03615220003785 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-01-12

Devices Manufactured by BIOSERENITY MEDICAL DEVICES GROUP

• 03615220003679 - Neuronaute Plus Touchproof Extender: 2024-05-30
• 03615220003983 - Neuronaute Plus- Holding Band: 2024-03-29
• 03615220003655 - Neuronaute Plus - DB25 Extender: 2024-02-28
• 03615220003662 - Neuronaute Plus- IceCap Extender: 2024-02-28
• 03615220003990 - Neuronaute Plus - Core Module: 2024-02-28
• 03615220004294 - Neuronaute Mobile Application Android: 2024-02-28
• 03615220001026 - Cardioskin Textile S20: 2023-12-28
• 03615220001033 - Cardioskin Textile S22: 2023-12-28