FDA.reportPublic FDA data

R-40 (24)

Primary DI
05060275450769
Brand
R-40 (24)
Company
LIFELINES LIMITED
Model
Amp + BT Kit
Catalog number
2605
Published
2020-01-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151600000R-40 EEG AmplifierLifelines , Ltd.2015-10-23GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060275450769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060275450769050602754507695060275450769

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441483224245wayne.williams@lifelinesneuro.com

Regulatory Flags#

DUNS number
237089235
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060275450714R-40 (24)Amp14112020-01-27
05060275450721R-40 (24)Amp + BT14122020-01-27
05060275450738R-40 (24)Amp + WI-FI14132020-01-27
05060275450745R-40 (24)Amp + BT + WI-FI14142020-01-27
05060275450752R-40 (24)Amp Kit26042020-01-27
05060275450776R-40 (24)Amp + WI-FI Kit26062020-01-27
05060275450783R-40 (24)Amp + BT + WI-FI Kit26072020-01-27
05060275450004TrackitTrackit 3 BT 24/011872016-09-09
05060275450011TrackitTrackit 3 BT 20/411842016-09-09
05060275450028TrackitTrackit 3 BT 18/811852016-09-09
05060275450035TrackitTrackit 3 BT 32/011862016-09-09
05060275450042TrackitTrackit 3 BT 24/0/B11722016-09-09
05060275450059TrackitTrackit 3 BT 20/4/B11692016-09-09
05060275450066TrackitTrackit 3 BT 18/8/B11702016-09-09
05060275450073TrackitTrackit 3 BT 32/0/B11712016-09-09
05060275450127Trackit SleepwalkerMK3 Standard13012019-01-18
05060275450134Trackit SleepwalkerMK3 + SaO213022019-01-18
05060275450141Trackit SleepwalkerMK3 + BT13032019-01-18
05060275450158Trackit SleepwalkerMK3 + SaO2 + BT13042019-01-18
05060275450172TrackitTrackit 3 BT 24/811882016-09-09

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Primary DI, Brand, Company table
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B195EE225eego amplifiereemagine Medical Imaging Solutions GmbHGWL2025-09-29
00817111021332PolysmithNeurotronics, LLCGWL2025-09-23
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWL2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWL2025-05-22
08056446901113NExT-PADEB NEURO SPAGWL2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWL2025-05-22
08056446901137NExT-HSEB NEURO SPAGWL2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWL2025-05-22
08056446901199NExT-ASEB NEURO SPAGWL2025-05-22
08056446901205NExT StationEB NEURO SPAGWL2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWL2025-05-19
00814901021541Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
00814901021558Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
08056446900673Neurotravel LIGHTEB NEURO SPAGWL2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWL2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWL2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWL2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWL2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWL2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWL2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWL2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWL2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWL2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWL2024-12-04
EBCI5730PRO0g.Nautilus PROg.tec medical engineering GmbHGWL2024-05-28
00814901021527Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2023-12-04