FDA.reportPublic FDA data

NA

Primary DI
04931921863596
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
JE-905P
Catalog number
JE-905P
Device description
CABLE, EEG PATIENT, 8CH, 5 ELECTRODE
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
04931921863596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921863596049319218635964931921863596

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690568050
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04931921049464NAMDI-1000MDI-10002026-05-20
04931921111697NAIF-949PIF-949P12026-05-20
14931921057541cap-ONEYG-213TYG-213T-A12026-04-20
04931921877401BluPRO®TL-601T0P3112026-02-03
14931921010232cap-ONEYG-220TYG-220T2023-05-22
14931921010270cap-ONEYG-221TYG-221T2023-05-22
14931921010300cap-ONEYG-230TYG-230T2023-05-22
14931921010331cap-ONEYG-231TYG-231T2023-05-22
14931921044350cap-ONE`YG-211TYG-211T-A12024-06-21
04931921025727cap-ONETG-980P1TG-980P12022-05-12
14931921838195NAYG-101TYG-101T2016-09-05
14931921869038cap-ONEYG-122TYG-122T2016-09-05
14931921877996NAYG-111TYG-111T2016-09-05
14931921883713cap-ONEYG-125TYG-125T2016-09-05
14931921883744cap-ONEYG-135TYG-135T2016-09-05
14931921885694NAYG-211TYG-211T2016-09-05
14931921886202cap-ONEYG-232TYG-232T2016-09-05
14931921890025NAYG-213TYG-213T2016-09-05
14931921895709cap-ONEYG-242TYG-242T2016-09-05
14931921899295NAYG-214TYG-214T2016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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