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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Zensoronline software - 05060484630044

The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution

  • 05060484630044 ()


  • Electrocardiography telemetric monitoring system

Zensor+ software - 05060484630051

The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0811
In Commercial Distribution

  • 05060484630051 ()


  • Electrocardiography telemetric monitoring system

CERVELLO SOFTWARE - 00850154007086

Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution

  • 00850154007086 ()
RS-0003

  • Electroencephalography telemetric monitoring system
  • Bioelectrical signal analysis software

eCardiostation Software - B147EC0

Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system

Diopsys® - 00850514007091

NOVA Software
DIOPSYS, INC.
NOVA 2.19
In Commercial Distribution

  • 00850514007091 ()


  • Vision electrophysiology analysis system

NaviCare® WatchChild® Systems - 00887761001572

Medical Software
HILL-ROM, INC.
1.6
In Commercial Distribution

  • 00887761001572 ()


  • Obstetrics information system application software

PACS Scan - 00850677007006

PACS Scan Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007006 ()


  • Radiography digital imaging scanner

PACS Scan CD - 00850677007112

PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner

Xltek - 00382830043458

RemLogic 3.4.1 (ENU) Software
Embla Systems Ltd
013974
In Commercial Distribution

  • 00382830043458 ()


  • Sleep disorder interpretive software

Embla - 00382830048484

RemLogic 4.0 Software (English)
Embla Systems Ltd
025406
In Commercial Distribution

  • 00382830048484 ()


  • Sleep disorder interpretive software
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