FDA.reportPublic FDA data

FUKUDA DENSHI

Primary DI
04538612907753
Brand
FUKUDA DENSHI
Company
FUKUDA DENSHI CO.,LTD.
Model
LX-7120
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04538612907753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04538612907753045386129077534538612907753

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring system transmitterA body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690671011
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04538612054181FUKUDA DENSHIABT-720D2026-04-23
04538612914256FUKUDA DENSHIABT-810D2023-01-06
04538612914263FUKUDA DENSHIOAT-03A2023-01-06
04538612061912FUKUDA DENSHIABT-X1C2026-04-23
04538612916359FUKUDA DENSHIDS-X1M2026-04-23
04538612916373FUKUDA DENSHIDS-X1N2026-04-23
04538612916410FUKUDA DENSHIOAT-X1A2026-04-23
04538612230554FUKUDA DENSHIOAT-07A0.752026-04-02
04538612916502FUKUDA DENSHIOAO-125A2026-04-02
04538612916540FUKUDA DENSHICJO-32RS0.12026-04-02
04538612228483FUKUDA DENSHIFCS-64G5511207902026-03-06
04538612916328FUKUDA DENSHILXN-10002025-12-16
04538612230455FUKUDA DENSHIOAO-123A2025-12-17
04538612916236FUKUDA DENSHICIT-13DIN3-0.3A2025-12-17
04538612916243FUKUDA DENSHICMO-03NTG-0.9A2025-12-17
04538612916250FUKUDA DENSHICMO-04NTG-0.9A2025-12-17
04538612916267FUKUDA DENSHICMO-05NTG-0.9A2025-12-17
04538612061905FUKUDA DENSHIABT-1300C2025-12-16
04538612916281FUKUDA DENSHILX-1300M2025-12-16
04538612916304FUKUDA DENSHILX-1300N2025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838132320Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
04048675723639Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675723646Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785477Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785484Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785491Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675786108Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797173Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797180Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797197Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
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