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
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
00850063034289Night ShiftNS27-4102.XXL2025-07-21
00850015266492Night ShiftNS27-41022022-03-29
00850015266508Night ShiftNS27-4102.XXL2022-03-29
00850063034265Night ShiftNS27-1010.LE2025-05-22
00851113007123Apnea GuardAG25-4107.202016-09-23
00850063034135X-SeriesXS30-1015.LE2025-01-29
00850063034166X-SeriesXS30-1001.LE2025-01-29
00850063034180X-SeriesXS30-1007.LE2025-01-29
00850063034128Sleep ProfilerSP29-1015.LE2025-01-28
00850063034142Sleep Profiler PSG2SP29-1002.LE2025-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDOMC2026-03-12
09357225002021Nurochek-Pro Application HEADSAFE MFG PTY LTDOMC2025-12-15
09357225002038Nurochek-Pro ServerHEADSAFE MFG PTY LTDOMC2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitHEADSAFE MFG PTY LTDOMC2025-12-15
09357225006029Nurochek-Pro Saline SolutionHEADSAFE MFG PTY LTDOMC2025-12-15
B675PDDU0Zeto ONE Display UnitZETO, INC.GWQ2025-11-19
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAGWQ2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWQ2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWQ2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWQ2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04