FDA.reportPublic FDA data

Neuronaute Plus- Holding Band

Primary DI
03615220003983
Brand
Neuronaute Plus- Holding Band
Company
BIOSERENITY MEDICAL DEVICES GROUP
Model
1001-05001-UN
Published
2024-03-21
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
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231366000Neuronaute PlusBioserenity Sas2023-11-09GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615220003983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615220003983036152200039833615220003983

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic ambulatory recorderA portable electrically-powered device designed for recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders; it is not intended for inpatient monitoring. It is a small unit designed to be worn by the patient with an appropriate signal amplifier, and intended to be used with a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) data is analysed after the recording period using an appropriate computer/software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
281224773
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
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
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
03615220003785BioSerenity-Link5100-00021-UN2023-01-12

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