Neuronaute Application Mobile iOS 5100-00012

GUDID 03615220002610

BIOSERENITY

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• Primary Device ID: 03615220002610
• NIH Device Record Key: e879c775-0b52-44ca-bedd-be0b646d2eb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuronaute Application Mobile iOS
• Version Model Number: 2.2.0
• Catalog Number: 5100-00012
• 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	03615220002610 [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

Devices Manufactured by BIOSERENITY

• 03615220004270 - Bioserenity Cloud: 2023-08-29 Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi conne
• 03615220004133 - Accusom: 2023-05-04 Sleep Apnea diagnostic Device
• 03615220004140 - Accusom: 2023-05-04 Breath sensor
• 03615220004157 - Accusom: 2023-05-04 Chest sensor
• 03615220004171 - Neuronaute Touchproof Adapter: 2023-05-02 The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one e
• 03615220001521 - Neuronaute IceCap: 2021-02-23 The Neuronaute IceCap is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array
• 03615220001774 - Neuronaute 1.2 - Head module: 2021-02-23 Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array
• 03615220002573 - Bioserenity Cloud: 2021-02-23