FDA.reportPublic FDA data

NA

Primary DI
04931921863602
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
BE-910P
Catalog number
BE-910P
Device description
ELECTRODE SET, DISK, SET/5
Published
2017-08-29
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
OMAAmplitude-integrated electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMAAmplitude-Integrated ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921863602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921863602049319218636024931921863602

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
00382830057745XltekXLTEKOMA2024-04-19
00382830061902XltekXLTEKOMA2024-04-19
50197106549979CARDINAL HEALTHCardinal Health 200, LLCOMA2024-02-12
00382830063067XltekXLTEKOMA2023-08-23
00382830059541XltekXLTEKOMA2023-07-26
00382830061742XltekXLTEKOMA2023-07-26
00382830061766XltekXLTEKOMA2023-07-26
00382830008679NatusXLTEKOMA2021-10-26
00382830007443NatusXLTEKOMA2021-10-07
B195ES820neoeemagine Medical Imaging Solutions GmbHOMA2020-02-26
B195LE800neoeemagine Medical Imaging Solutions GmbHOMA2020-02-26
00382830048231XltekXLTEKOMA2018-11-20
00382830048255XltekXLTEKOMA2018-11-20
00382830048279XltekXLTEKOMA2018-11-20
00382830048293XltekXLTEKOMA2018-11-20
00382830043380NatusXLTEKOMA2018-08-21
00382830047210NatusXLTEKOMA2018-07-12
04931921002896NANIHON KOHDEN CORPORATIONOMA2017-10-11
04931921863596NANIHON KOHDEN CORPORATIONOMA2017-08-29
00841983104077NANIHON KOHDEN AMERICA, INC.OMA2017-08-29
00841983104084NANIHON KOHDEN AMERICA, INC.OMA2017-08-29
00841983104091NANIHON KOHDEN AMERICA, INC.OMA2017-08-29
00841983104107NANIHON KOHDEN AMERICA, INC.OMA2017-08-29
00841983104114NANIHON KOHDEN AMERICA, INC.OMA2017-08-29
04931921863954NANIHON KOHDEN CORPORATIONOMA2017-08-10
04931921888476NANIHON KOHDEN CORPORATIONOMA2017-08-10
00382830004053Olympic CFMNATUS MEDICAL INCORPORATEDOMA2017-03-31
07290102932405Cerebralogik aEEG M.T.R.E. ADVANCED TECHNOLOGIES LTD.OMA2016-09-24
00382830010818NatusXLTEKOMA2016-09-20
00382830010825NatusXLTEKOMA2016-09-20