FDA.reportPublic FDA data

NA

Primary DI
04931921819142
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
NE-134A
Catalog number
NE-134A
Device description
EEG collodian electrode set, DIN
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLTNon-normalizing quantitative electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921819142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921819142049319218191424931921819142

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags#

DUNS number
690568050
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04931921877401BluPRO®TL-601T0P3112026-02-03
04931921044353cap-ONE`YG-211TYG-211T-A12024-06-21
04931921017524NAZR-920PZR-920P-FT2024-01-25
04931921017159CNS-2101 Central MonitorCNS-2101CNS-21012023-10-30
04931921007723Nihon Kohden, EEG-1200A Series NeurofaxKD-029A-01KD-029A-012019-07-24
04931921007730Nihon Kohden, EEG-1200A Series NeurofaxKE-122A-01KE-122A-012019-07-24
04931921017166CNS-2101 Central MonitorCNS-2101CNS-21012023-10-01
04931921010235cap-ONEYG-220TYG-220T2023-05-22
04931921010273cap-ONEYG-221TYG-221T2023-05-22
04931921010303cap-ONEYG-230TYG-230T2023-05-22
04931921010334cap-ONEYG-231TYG-231T2023-05-22
04931921007631Nihon Kohden, EEG-1200A Series NeurofaxJE-921A-01JE-921A-012019-07-24
04931921007709Nihon Kohden, EEG-1200A Series NeurofaxLS-703A-01LS-703A-012019-07-24
04931921007716Nihon Kohden, EEG-1200A Series NeurofaxLS-706A-01LS-706A-012019-07-24
04931921025727cap-ONETG-980P1TG-980P12022-05-12
04931921005828BluPRO®TL-271T3TL-271T3-A242022-04-06
04931921000045Smart Cable NMT Module and AccessoriesDH-101PDH-101P2021-09-27
04931921002018Nihon Kohden Life Scope G5 Bedside Monitoring SystemCU-151RCU-151R2021-09-27
04931921002056Nihon Kohden Life Scope G5 Bedside Monitoring SystemCU-152RCU-152R2021-09-27
04931921002087N/AAA-174PAA-174P2021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860410000379Q21NEUROFIELD, INC.OLT2025-06-02
10840067103996CadwellCADWELL INDUSTRIES, INC.OLT2024-08-23
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCOLT2024-05-13
00195278466662E-EEGXGE Healthcare Finland OyOLT2022-07-01
00841983104329NeurofaxNIHON KOHDEN AMERICA, INC.OLT2021-08-06
05694110068057Stratus EEGKvikna Medical ehf.OLT2021-01-28
05694110068064Stratus EEGKvikna Medical ehf.OLT2021-01-28
05694110068071Stratus EEGKvikna Medical ehf.OLT2021-01-28
B485VIS100CNS EnvisionMOBERG RESEARCH INCOLT2020-10-28
05694110068040Stratus EEGKvikna Medical ehf.OLT2020-09-01
04931921009161NeurofaxNIHON KOHDEN CORPORATIONOLT2020-03-24
04931921007723Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
04931921007730Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
04931921007631Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
04931921007716Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
00840067102718Cascade IOMAX Intraoperative MonitorCADWELL INDUSTRIES, INC.OLT2019-07-09
00840067102688IOMAX AdapterCADWELL INDUSTRIES, INC.OLT2019-05-13
00869732000135Persyst Mobile App PERSYST DEVELOPMENT CORPOLT2019-04-08
00840067102251ApolloCADWELL INDUSTRIES, INC.OLT2018-08-21
B485CNSINX3001Component Neuromonitoring SystemMOBERG RESEARCH INCOLT2018-06-06
B485CNSINX3201Component Neuromonitoring SystemMOBERG RESEARCH INCOLT2018-06-06
B485CNS3101Component Neuromonitoring SystemMOBERG RESEARCH INCOLT2017-12-21
05694110063090Lifelines iEEGKvikna Medical ehf.OLT2017-11-09
04931921004357NANIHON KOHDEN CORPORATIONOLT2017-09-27
00840067102244Cadwell Disposable Goggle FoamCADWELL INDUSTRIES, INC.OLT2017-07-11
00841983104008Polysmith Sleep SystemNIHON KOHDEN AMERICA, INC.OLT2017-05-24
00841983103995NANIHON KOHDEN AMERICA, INC.OLT2017-05-17
00841983103988NeurofaxNIHON KOHDEN AMERICA, INC.OLT2017-04-26
00841983103971NEUROFAXNIHON KOHDEN AMERICA, INC.OLT2016-11-18
05694110063052Lifelines iEEG Client SoftwareKvikna Medical ehf.OLT2016-10-03