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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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Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.
Philips Medical Systems Nederland B.V.
Dynamic Coronary Roadmap - 1
In Commercial Distribution

  • 00884838080805 ()
001016

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.
Philips Medical Systems Nederland B.V.
HeartNavigator - 3
In Commercial Distribution

  • 00884838080744 ()
001001

  • Angiographic x-ray system application software
Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.
Philips Medical Systems Nederland B.V.
EchoNavigator - 3
In Commercial Distribution

  • 00884838080737 ()
001011

  • Angiographic x-ray system application software
No Description
Philips Medizin Systeme Böblingen GmbH
866063
In Commercial Distribution

  • 00884838076532 ()
866063

  • Multiple vital physiological parameter monitoring system, clinical
Software medical device, used with a Philips Interventional X-Ray System. Provides quantitative information about coronary arteries, peripheral arteries, and ventricles.
Philips Medical Systems Nederland B.V.
2D Quantitative Analysis - 1
In Commercial Distribution

  • 00884838075863 ()
001014

  • Angiographic x-ray system application software
No Description
Edan Instruments, Inc.
MFM-CMS
In Commercial Distribution

  • 06944413800229 ()


  • Centralized patient monitor
ENG CONTROL 220V 50HZ W 8 SLOTS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351279 ()
SCNODE-DAB-AXXFX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 0 telemetry channels (single display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351262 ()
SCSYS-IAB-ADFCA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 8 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inte
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351255 ()
SCSYS-IAB-FDFCA

  • Centralized patient monitor
CSAS Episodic High Availability
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094345704 ()
106900-HA

  • Centralized patient monitor
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