Home GUDID 03615220003792 Neuronaute IceCap 2 Small
Primary DI 03615220003792
Brand Neuronaute IceCap 2 Small
Company BIOSERENITY MEDICAL DEVICES GROUP
Model 1001-01015-UN
Device description The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
Published 2023-01-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name GXY Electrode, Cutaneous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXY Electrode, Cutaneous Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03615220003792 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03615220003792 03615220003792 3615220003792
GMDN Terms# Term, Definition table Term Definition Electroencephalographic electrode cap, single-use An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap-like device with integrated scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Atmospheric Pressure 700 KiloPascal 1060 KiloPascal Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 281224773 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03615220004355 Neuronaute IceCap 2 Small 1001-01026-UN 2026-03-17 03615220004331 Neuronaute IceCap 2 1001-01025-UN 2025-11-28 03615220003846 Neuronaute Touchproof Adapter 1001-15024-UN 1001-15024-US 2025-04-17 03615220003471 Neuronaute - IceAdapter 1001-15020-US 2023-01-12 03615220003617 Neuronaute IceCap 2 1001-01014-UN 2023-01-25 03615220003624 Neuronaute - IceAdapter 1001-15020-UN 2025-04-18 03615220004171 Neuronaute Touchproof Adapter 1001-15024-US 1001-15024-US 2023-04-24 03615220003952 Neuronaute® IceCap Neonate (M) 1001-01018-UN 2025-04-17 03615220003969 Neuronaute® IceCap Neonate (S) 1001-01019-UN 2025-04-17 03615220003976 Neuronaute® IceCap Neonate (XS) 1001-01020-UN 2025-04-17 03615220003679 Neuronaute Plus Touchproof Extender 1001-15023-UN 2024-05-22 03615220003983 Neuronaute Plus- Holding Band 1001-05001-UN 2024-03-21 03615220003655 Neuronaute Plus - DB25 Extender 1001-15021-UN 2024-02-20 03615220003662 Neuronaute Plus- IceCap Extender 1001-15022-UN 2024-02-20 03615220003990 Neuronaute Plus - Core Module 1001-10006-US 2024-02-20 03615220004294 Neuronaute Mobile Application Android 5100-00024 2024-02-20 03615220001729 Neuronaute 1.2 - High capacity battery module 1001-15016-UN 2023-01-12 03615220001781 Neuronaute 1.2 - BioAdapter 1001-15015-US 2023-01-12 03615220001798 Neuronaute 1.2 - Battery charger 1001-15017-US 2023-01-12 03615220003785 BioSerenity-Link 5100-00021-UN 2023-01-12
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