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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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2-Channel Invasive Pressure Universal Cable
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2108
In Commercial Distribution

  • 05060472440716 ()


  • Multiple vital physiological parameter monitoring system, clinical
Consumables Replenishment Kit
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1020
Not in Commercial Distribution

  • 05060472440709 ()


  • Multiple vital physiological parameter monitoring system, clinical
Mains Power Supply
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1017
Not in Commercial Distribution

  • 05060472440693 ()


  • Multiple vital physiological parameter monitoring system, clinical
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023711 ()
MG1000

  • Cardiac mapping system
Tempus IC2 Patient Monitor
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-2001-R
Not in Commercial Distribution

867374

  • Multiple vital physiological parameter monitoring system, clinical
Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2, Temp & IBP
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1026-R
In Commercial Distribution

867423

  • Multiple vital physiological parameter monitoring system, clinical
Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2 & Temp
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1024-R
In Commercial Distribution

867422

  • Multiple vital physiological parameter monitoring system, clinical
Tempus Pro Rainbow - with Capnometry & with BT Dock
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1007-R
In Commercial Distribution

867421

  • Multiple vital physiological parameter monitoring system, clinical
Tempus Pro Rainbow - with Capnometry & without BT Dock
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1004-R
In Commercial Distribution

867420

  • Multiple vital physiological parameter monitoring system, clinical
The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set. Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution

  • 05060508110002 ()


  • Angiographic x-ray system application software
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