FDA.reportPublic FDA data

NA

Primary DI
04931921114803
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
YS-097P5
Catalog number
YS-097P5
Device description
VL cable set (Main), cable length
Published
2016-09-05
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
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921114803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921114803049319211148034931921114803

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system central station 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
+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
00884838119079Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119086Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119093Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119109Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119116Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119123Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119147Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119154Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119161Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119178Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838128880Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
04538612228483FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-03-06
00884838086678Masimo Sedline ModulePhilips Medizin Systeme Böblingen GmbHMHX2026-01-15
00199874152509MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
00199874432199MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
04538612916236FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916243FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916250FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916267FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612061905FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916281FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916304FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916403FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
00884838127074Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838107809Patient Monitor 6500Philips Medizin Systeme Böblingen GmbHMHX2025-11-11
06944413838420Patient MonitorEdan Instruments, Inc.MHX2025-09-05