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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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CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932242 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive
No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria
icometrix NV
1.1
In Commercial Distribution

  • B621ICOBRAINARIA1X1Y0 ()


  • Radiology DICOM image processing application software
ASSY CLABII PLUS64 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
64 Channel
Not in Commercial Distribution

  • 00840682119634 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
ASSY CLABII PLUS128 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
128 Channel
In Commercial Distribution

  • 00840682119603 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction
CAMERA, 0°
INTUITIVE SURGICAL, INC.
430077
In Commercial Distribution

  • 00886874122228 ()

  • Outer Diameter: 6 Millimeter


  • Rigid optical laparoscope
DVD SOFTWARE HSCRIBE V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356878 ()
109202

  • Electrocardiographic long-term ambulatory recording analyser application software
DVD SOFTWARE VISION V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356861 ()
109203

  • Electrocardiographic long-term ambulatory recording analyser application software
HS6 SERVER RX KIT DICOM PDF XML
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094350753 ()
HSERV-6BA-XXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software
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