FDA.reportPublic FDA data

CNS-2101 Central Monitor

Primary DI
04931921017166
Brand
CNS-2101 Central Monitor
Company
NIHON KOHDEN CORPORATION
Model
CNS-2101
Catalog number
CNS-2101
Device description
Central Monitor
Published
2023-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DRQAmplifier And Signal Conditioner, Transducer Signal
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
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223567000CNS-2101 Central MonitorNihon Kohden Corporation2023-07-31MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921017166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921017166049319210171664931921017166

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690568050
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14931921902902BLUPRO Attachment TapeYS-111P7P263A2026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
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17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-07-21
03615041990578Capsule SurveillancePhilips North America LLCMWI2026-07-14
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
08684906452600Arc SystemM2AN DIGITAL HEALTH INC.MWI2026-06-29
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201017Gas Sample Line SetMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
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08720256776987Charge Station 10 Sensors ACorsano Health B.V.MSX2026-06-02
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B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27