FDA.reportPublic FDA data

Neuronaute Mobile Application Android

Primary DI
03615220004294
Brand
Neuronaute Mobile Application Android
Company
BIOSERENITY MEDICAL DEVICES GROUP
Model
5100-00024
Published
2024-02-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615220004294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615220004294036152200042943615220004294

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
281224773
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615220004355Neuronaute IceCap 2 Small1001-01026-UN2026-03-17
03615220004331Neuronaute IceCap 21001-01025-UN2025-11-28
03615220003846Neuronaute Touchproof Adapter1001-15024-UN1001-15024-US2025-04-17
03615220003471Neuronaute - IceAdapter1001-15020-US2023-01-12
03615220003617Neuronaute IceCap 21001-01014-UN2023-01-25
03615220003624Neuronaute - IceAdapter1001-15020-UN2025-04-18
03615220003792Neuronaute IceCap 2 Small 1001-01015-UN2023-01-25
03615220004171Neuronaute Touchproof Adapter1001-15024-US1001-15024-US2023-04-24
03615220003952Neuronaute® IceCap Neonate (M)1001-01018-UN2025-04-17
03615220003969Neuronaute® IceCap Neonate (S)1001-01019-UN2025-04-17
03615220003976Neuronaute® IceCap Neonate (XS)1001-01020-UN2025-04-17
03615220003679Neuronaute Plus Touchproof Extender1001-15023-UN2024-05-22
03615220003983Neuronaute Plus- Holding Band1001-05001-UN2024-03-21
03615220003655Neuronaute Plus - DB25 Extender1001-15021-UN2024-02-20
03615220003662Neuronaute Plus- IceCap Extender1001-15022-UN2024-02-20
03615220003990Neuronaute Plus - Core Module 1001-10006-US2024-02-20
03615220001729Neuronaute 1.2 - High capacity battery module1001-15016-UN2023-01-12
03615220001781Neuronaute 1.2 - BioAdapter1001-15015-US2023-01-12
03615220001798Neuronaute 1.2 - Battery charger1001-15017-US2023-01-12
03615220003785BioSerenity-Link5100-00021-UN2023-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28