FDA.reportPublic FDA data

Neuronaute Touchproof Adapter

Primary DI
03615220004171
Brand
Neuronaute Touchproof Adapter
Company
BIOSERENITY MEDICAL DEVICES GROUP
Model
1001-15024-US
Catalog number
1001-15024-US
Device description
The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
Published
2023-04-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202334000
K223644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202334000NeuronauteBioserenity Sas2020-12-10GWQ
K223644000Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity2023-01-12GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615220004171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615220004171036152200041713615220004171

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic electrode cap, single-useAn 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
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
281224773
Device count
1
Lot or batch
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
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
03615220003785BioSerenity-Link5100-00021-UN2023-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
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00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08