FDA.reportPublic FDA data

X-Series

Primary DI
00851113007475
Brand
X-Series
Company
ADVANCED BRAIN MONITORING, INC.
Model
ES31-1001, ES31-1003
Device description
External Syncing Unit - Multi-Channel Kit
Published
2016-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131383000X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWAREAdvanced Brain Monitoring, Inc.2013-11-27GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851113007406Direct MarkingGS10
00851113007475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851113007406008511130074068511130074060851113007406
00851113007475008511130074758511130074750851113007475

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Regulatory Flags#

DUNS number
969842715
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063034401Sleep Profiler PSG2SP29-1017.LE2026-09-25
00850063034418Sleep Profiler PSG2SP29-1018.LE2026-09-25
00850063034425Sleep ProfilerSP29-1020.LE2026-09-25
00850063034432Sleep ProfilerSP29-1020.LE(ITA)2026-09-25
00850063034449Sleep ProfilerSP29-1021.LE2026-09-25
00850063034456Sleep ProfilerSP29-1022.LE2026-09-25
00850063034470Sleep ProfilerSP29-1025.LE2026-09-25
00850063034487Sleep ProfilerSP29-1026.LE2026-09-25
00850063034494Sleep ProfilerSP29-1027.LE2026-09-25
00850063034524Sleep ProfilerSP29-1020.LE(GER)2026-09-25
00850063034364Sleep ProfilerSP40-1001.LE(GRE)2025-12-22
00850063034296Night ShiftNS27-1010.LE2025-12-08
00850063034319Night ShiftNS27-1005.LE(FIN)2025-12-08
00850063034326Night ShiftNS27-1005.LE(NOR)2025-12-08
00850063034333Night ShiftNS27-1005.LE(SWE)2025-12-08
00850063034357Night ShiftNS27-1010.LE(FRE)2025-12-08
00850063034340Night ShiftNS27-1010.LE(ENSO)2025-11-14
70850015266194Night ShiftNS27-1005.LE(ENSO)2025-10-27
00850063034302Night ShiftNS27-1005.LE(DAN)2025-08-21
00850063034272Night ShiftNS27-41022025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824045Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.OMC2026-09-04
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
B566847020ZmachineGeneral SleepOMC2026-04-16
B566847001ZmachineGeneral SleepOMC2026-04-09
B566847002ZmachineGeneral SleepOMC2026-04-09
B592SW100WAVi Scan SoftwareWAVI CO.GWQ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWQ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25
09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2026-03-18
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09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
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