FDA.reportPublic FDA data

Central Station

Primary DI
00851725007399
Brand
Central Station
Company
Nihon Kohden Digital Health Solutions, LLC
Model
CNSCS-001
Device description
Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters.
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRQAmplifier And Signal Conditioner, Transducer Signal
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MSXSystem, Network And Communication, Physiological Monitors
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242750000Central StationNihon Kohden Digital Health Solutions, LLC2025-06-05MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851725007399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851725007399008517250073998517250073990851725007399

GMDN Terms#

Term, Definition table
TermDefinition
Centralized patient monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(949) 474-9207info@nkdhs.com

Regulatory Flags#

DUNS number
126381560
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851725007368NetKonnect CentralNKCNS-0012026-03-31
00851725007351Next Generation NetKonnectNGNK-6801NGNK-68012023-06-05
00851725007115Next Generation NetKonnectNGNK-6803-MNGNK-6803-M2022-08-31
00851725007306Next Generation NetKonnectNGNK-6803NGNK-68032022-08-31
00851725007313Next Generation NetKonnectNGNK-6804NGNK-68042022-08-31
00851725007320Next Generation NetKonnectNGNK-6803-TNGNK-6803-T2022-08-31
00851725007337Next Generation NetKonnectNGNK-6804-MNGNK-6804-M2022-08-31
00851725007344Next Generation NetKonnectNGNK-6804-TNGNK-6804-T2022-08-31
00851725007269Remote Network StationRNS-6804-7490-URNS-6804-7490-U2021-09-30
00851725007276Remote Network StationRNS-6803-7490-URNS-6803-7490-U2021-09-30
00851725007283Remote Network StationRNS-6804-7490RNS-6804-74902021-09-30
00851725007290Remote Network StationRNS-6803-7490RNS-6803-74902021-09-30
00851725007245Remote Network StationRNS-6804-7480-URNS-6804-7480-U2021-05-26
00851725007252Remote Network StationRNS-6803-7480-URNS-6803-7480-U2021-05-26
00851725007221Remote Network StationRNS-6804-7480RNS-6804-74802020-12-23
00851725007238Remote Network StationRNS-6803-7480RNS-6803-74802020-12-23
00851725007214PrefenseEDNS-9001-AVGH977EDNS-9001-AVGH9772020-10-31
00851725007177Remote Network StationRNS-6804-7460RNS-6804-74602020-03-25
00851725007184Remote Network StationRNS-6803-7460RNS-6803-74602020-03-25
00851725007191Remote Network StationRNS-6803-7470RNS-6803-74702020-03-25

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Primary DI, Brand, Company table
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