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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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The A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse wave acquisition device, a blood pressure (BP) calibrator and the A-PULSE CASP® pulse wave application software. The BPro® device is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed. The MC3100™ oscillometric blood pressure monitor, or an equivalent, may be used as the BP calibrator.
HEALTHSTATS INTERNATIONAL PTE LTD
T6400 Series
Not in Commercial Distribution

  • 08885014410036 ()


  • Blood pressure ambulatory recorder
The MC3100™ is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate.
HEALTHSTATS INTERNATIONAL PTE LTD
T3100 Series
Not in Commercial Distribution

  • 08885014410029 ()


  • Blood pressure ambulatory recorder
BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410012 ()


  • Blood pressure ambulatory recorder
The BPro® BT is used to capture the pulse wave from the radial artery.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 series
In Commercial Distribution

  • 08885014410005 ()


  • Blood pressure ambulatory recorder
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software
Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. It is intended to be used for verification / re-verification of correct MRI scanner sequence configuration for the use of R2-MRI Analysis System (FerriScan)
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0 (15 vials (0 to 3.2 mM))
In Commercial Distribution



  • MRI phantom, test object
No Description
Manus Medical, LLC
B9-18339
In Commercial Distribution

  • 20811870035221 ()
  • 00811870035227 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B446MM-B
In Commercial Distribution

  • 20811870031131 ()
  • 00811870031137 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B9-18339B
In Commercial Distribution

  • 20811870030714 ()
  • 00811870030710 ()


  • Mammographic stereotactic biopsy system
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