FDA.reportPublic FDA data

Neuronaute Application Mobile iOS

Primary DI
03615220002610
Brand
Neuronaute Application Mobile iOS
Company
BIOSERENITY MEDICAL DEVICES GROUP
Model
5100-00012
Published
2021-02-15
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
03615220002610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615220002610036152200026103615220002610

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalography telemetric monitoring system transmitterA body-worn, battery-powered component of an electroencephalography telemetric monitoring system designed to continuously measure and wirelessly transmit electroencephalographic (EEG) signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. This is a reusable device.

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
03615220004294Neuronaute Mobile Application Android5100-000242024-02-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
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