FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications

CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04538612907753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04538612907753045386129077534538612907753

GMDN Terms

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

Regulatory Flags

DUNS number
690671011
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
04538612228483FUKUDA DENSHIFCS-64G5511207902026-03-06
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
04538612916328FUKUDA DENSHILXN-10002025-12-16
04538612916403FUKUDA DENSHILX-1300E2025-12-16
04538612916335FUKUDA DENSHIHN-1002025-05-29
04538612228698FUKUDA DENSHISD-16G2025-03-11
04538612100970FUKUDA DENSHIEE-502025-02-28
04538612100987FUKUDA DENSHIEE-512025-02-28
04538612101007FUKUDA DENSHIOAE-57A2025-02-28
04538612122460FUKUDA DENSHIOAE-51A2025-02-28
04538612915772FUKUDA DENSHICPE-01AKPA-20382025-02-28
04538612916014FUKUDA DENSHIFP-908LP2025-02-28
04538612916120FUKUDA DENSHIBDS-1001ENT2024-10-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
06944413838451Patient MonitorEdan Instruments, Inc.MHX2025-09-05
07613365004168ARGUS PB-3000Schiller AGMHX2025-08-19
07613365004359ARGUS PB-3000Schiller AGMHX2025-08-19
00816787024388Remote Control RF 2100 With PadsPARKS MEDICAL ELECTRONICS, INC.MHX2025-07-18
00690103219111CableEdwards Lifesciences LLCMHX2025-07-15
04538612916335FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-05-29
00884838127067Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2025-05-13
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-05-06
10889483574324Vital Signs™AirLife Finland OyMHX2025-03-31