Neuronaute IceCap 1001-01010-US

GUDID 03615220001521

The Neuronaute IceCap is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.

BIOSERENITY

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• Primary Device ID: 03615220001521
• NIH Device Record Key: 66f43a0f-62af-4ebe-9dc2-b461e7b938e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuronaute IceCap
• Version Model Number: 1.2
• Catalog Number: 1001-01010-US
• Company DUNS: 265828238
• Company Name: BIOSERENITY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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	03615220001521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202334

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2021-02-23The Neuronaute IceCap is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.
• 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