FDA.reportPublic FDA data

Bio Protech

Primary DI
00817120021200
Brand
Bio Protech
Company
BIO PROTECH USA, INC.
Model
RGEEG-15 (Lifelines)
Device description
RGEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups
Published
2017-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153019000Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc.2016-03-21GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817120021207PackageGS110In Commercial Distribution
20817120021204PackageGS15In Commercial Distribution
00817120021200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712002120710817120021207
2081712002120420817120021204
00817120021200008171200212008171200212000817120021200

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Contacts#

Phone, Email table
PhoneEmail
909-464-1464support@bioprotechusa.com

Regulatory Flags#

DUNS number
789127011
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817120020050Bio Protech48482026-05-07
00817120020043Bio Protech48482016-06-15
00817120020340Bio Protech4848WCBZGN(NST)2016-06-21
00817120021088Bio ProtechSG15R (Lifelines)2017-08-09
00817120021095Bio ProtechSG15G (Lifelines)2017-08-09
00817120021101Bio ProtechNCS-1334 (Lifelines)2017-08-09
00817120021118Bio ProtechNCS-SG15 (Lifelines)2017-08-09
00817120021125Bio ProtechMF2409 (Lifelines)2017-08-09
00817120020005Bio Protech MaxTens 1k 2016-06-15
00817120020074Bio ProtechMaxEMS 1k2016-06-16
00817120020081Bio Protech MaxEMS 2k2016-06-17
00817120020562Bio Protech MaxTens 1k Unit2016-09-01
00817120020036Bio Protech MaxTens 2k 2016-06-16
00817120021132Bio ProtechDEEG-A-10 (Lifelines)2017-08-09
00817120021149Bio ProtechDEEG-A-12 (Lifelines)2017-08-09
00817120021156Bio ProtechDEEG-A-15 (Lifelines)2017-08-09
00817120021163Bio ProtechDEEG-A-20 (Lifelines)2017-08-09
00817120021170Bio ProtechRGEEG-05 (Lifelines)2017-08-09
00817120021187Bio ProtechRGEEG-10 (Lifelines)2017-08-09
00817120021194Bio ProtechRGEEG-12 (Lifelines)2017-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02