FDA.reportPublic FDA data

NA

Primary DI
00841983104091
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
AE-918P-LG/ZA
Catalog number
AE-918P-LG/ZA
Device description
EEG POD ACCESSORY KIT 8CH LARGE, AE-918
Published
2017-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMAAmplitude-integrated electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMAAmplitude-Integrated ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983104091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983104091008419831040918419831040910841983104091

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
021063219
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841983101493NAYG-101TYG-101T2016-09-19
10841983101509NAYG-111TYG-111T2016-09-19
10841983101516cap-ONEYG-122TYG-122T2016-09-19
10841983101523NAYG-211TYG-211T2016-09-19
10841983101530NAYG-213TYG-213T2016-09-19
10841983101547NAYG-214TYG-214T2016-09-19
10841983101554cap-ONEYG-232TYG-232T2016-09-19
10841983101561cap-ONEYG-242TYG-242T2016-09-19
10841983102766cap-ONEYG-125TYG-125T2016-09-19
10841983102773cap-ONEYG-135TYG-135T2016-09-19
10841983102780cap-ONEYG-225TYG-225T2016-09-19
10841983102797cap-ONEYG-235TYG-235T2016-09-19
00841983100673NAJG-900PJG-900P2016-09-19
00841983101434NATG-101TTG-101T2016-09-19
00841983102295NAOLG-2800AOLG-2800A2016-09-19
00841983102622NATG-900PTG-900P2016-09-19
00841983102639cap-ONETG-920PTG-920P2016-09-19
00841983102646cap-ONETG-921T3TG-921T32016-09-19
00841983102653cap-ONETG-970PTG-970P2016-09-19
10841983101592NAYG-921PYG-921P2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850056774017NeuroMatchLVIS CORPORATIONOMA2026-05-12
09120109830269encevisAIT Austrian Institute of Technology GmbHOMA2025-08-05
00850056774000NeuroMatchLVIS CORPORATIONOMA2025-04-04
00382830057745XltekXLTEKOMA2024-04-19
00382830061902XltekXLTEKOMA2024-04-19
10197106549971CARDINAL HEALTHCardinal Health 200, LLCOMA2024-02-12
50197106549979CARDINAL HEALTHCardinal Health 200, LLCOMA2024-02-12
00382830063067XltekXLTEKOMA2023-08-23
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATEDOMA2023-08-18
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830059541XltekXLTEKOMA2023-07-26
00382830061742XltekXLTEKOMA2023-07-26
00382830061766XltekXLTEKOMA2023-07-26
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOMA2023-07-24
09120109830122encevisAIT Austrian Institute of Technology GmbHOMA2022-07-15
00382830008679NatusXLTEKOMA2021-10-26
00382830007450NatusXLTEKOMA2021-10-07
00382830007443NatusXLTEKOMA2021-10-07
00382830058209NatusXLTEKOMA2021-04-20
00382830058216NatusXLTEKOMA2021-04-20
00382830058575NatusXLTEKOMA2021-04-20
B485CNSPTZ3501Component Monitoring SystemMOBERG RESEARCH INCOMA2021-04-19
B485CNS3501Component Neuromonitoring SystemMOBERG RESEARCH INCOMA2021-02-12
09120109830078encevisAIT Austrian Institute of Technology GmbHOMA2021-01-11