FDA.reportPublic FDA data

X-Series

Primary DI
00851113007918
Brand
X-Series
Company
ADVANCED BRAIN MONITORING, INC.
Model
ES31-1001, ES31-1003
Device description
External Syncing Unit - Multi-Channel Kit (PAN 1026A)
Published
2018-08-21
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
00851113007901Direct MarkingGS10
00851113007918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851113007901008511130079018511130079010851113007901
00851113007918008511130079188511130079180851113007918

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a 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.

Sterilization Methods#

Method table
Method

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