FDA.reportPublic FDA data

Ethernet Switch

Primary DI
00850011306253
Brand
Ethernet Switch
Company
NEURALYNX, INC.
Model
Ethernet Switch
Catalog number
31-0604-0139
Device description
The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
Published
2024-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110967000ENTERPRISE ELECTROPHYSIOLOGY SYSTEMNeuralynx, Inc.2011-06-30OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011306253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011306253008500113062538500113062530850011306253

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933200842
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011306314ATLAS Cart - Dual Monitors31-0605-016931-0605-01692026-04-27
00850011306291High Density Tether 7.5m7.5 meter31-0202-00072026-02-19
00850011306307Tether Extension Cable Male-to-Male 3m3 meter31-0613-00312026-02-19
00850011306338ATLAS Stim Headbox - TouchproofTouchproof31-0601-00892025-06-11
00850011306345ATLAS Stim Headbox - High DensityHigh Density31-0601-01322025-06-11
00850011306703ATLAS Stim Headbox Software1.5.136-0301-00062025-06-11
00850011306710Fiber Optic Connector 2m2m31-0204-00012025-06-11
00850011306727Fiber Optic Connector 7m7m31-0204-00022025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofTouchproof31-0204-00042025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNK31-0204-00032025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityHigh Density31-0204-00052025-06-11
00867718000285ATLAS Stim Headbox - NKNK31-0601-00772025-06-11
00850011306512ATLAS Headbox Expansion PanelATLAS HEP31-0607-00142022-11-10
00850011306970Zipshield 8m8m31-0604-01292024-12-11
00850011306932ATLAS Workstation MonitorATLAS Workstation Monitor31-0000-00022024-12-18
00850011306949ATLAS WorkstationATLAS Workstation31-0004-00002024-12-18
00850011306956ATLAS Parallel TTL CableATLAS Parallel TTL Cable31-0602-00242024-12-18
00850011306239ATLAS Rackmounted Power IsolatorATLAS Rackmounted Power Isolator31-0607-00152024-12-11
00850011306963Zipshield 5m5m31-0604-01282024-12-11
00850011306987ATLAS Power Isolator 110VAC110VAC31-0607-00082024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011306314ATLAS Cart - Dual MonitorsNEURALYNX, INC.OMC2026-04-27
05999860882046QUEX EDQX WORLD LTDOMC2026-04-27
05999860882053QUEX SQX WORLD LTDOMC2026-04-27
05999860882060QUEX EDQX WORLD LTDOMC2026-04-27
05999860882077QUEX SQX WORLD LTDOMC2026-04-27
B566847020ZmachineGeneral SleepOMC2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOMC2026-04-15
B566847001ZmachineGeneral SleepOMC2026-04-09
B566847002ZmachineGeneral SleepOMC2026-04-09
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
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDOMC2026-01-23
00850063034364Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2025-12-22
09357225000034Nurochek-ProHEADSAFE MFG PTY LTDOMC2025-12-15
09357225001017Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2025-12-15
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
B706H10000COGNISION EEG/EP SystemNeuronetrix Solutions, LLCOMC2025-03-12
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