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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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Tempus IC2 - 05060472442949

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 - 05060472442932

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 - 05060472442925

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 - 05060472442918

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 - 05060472442901

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

Cydar EV - 05060508110002

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

CardioInsight™ - 00643169723603

MAPPING SYSTEM CIT200 CIT US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00643169723603 ()


  • Cardiac mapping system

Corsium Crew Application - 05060472441348

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2508
Not in Commercial Distribution

  • 05060472441348 ()


  • Multiple vital physiological parameter monitoring system, clinical

Philips IntelliSpace Corsium - 05060472441331

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2507
In Commercial Distribution

  • 05060472441331 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472441256

Smart Mount
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2244
In Commercial Distribution

  • 05060472441256 ()


  • Multiple vital physiological parameter monitoring system, clinical
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