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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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Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.0
In Commercial Distribution

  • B180BSB01100 ()
BSB01

  • Blood bank information system application software
No Description
ECENTIAL ROBOTICS
L00016
In Commercial Distribution

  • 03701311500445 ()


  • Robotic surgical navigation system application software
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software
Raypilot Software, including user friendly functions, is installed on a dedicated computer and visualized on a display in the control as well as treatment room.
Micropos Medical AB (Publ)
1
In Commercial Distribution

  • 07350007953049 ()
3004

  • Radiation therapy invasive marker lesion localization system
moorVMS-PC Software V4.0 is a Windows based software package designed to work with the moorVMS setup and is fully compatible with all of the existing modules.
MOOR INSTRUMENTS LIMITED
4
In Commercial Distribution

  • 15060484490096 ()


  • Tissue saturation oximeter
  • Laser Doppler blood flowmeter
No Description
PATHKEEPER SURGICAL LTD
PSW0001-01
In Commercial Distribution

  • 07290019120148 ()


  • Optical surgical navigation device tracking system
iCodeConnect Software
BMC Medical Co., Ltd.
420002
In Commercial Distribution

  • 06948538362075 ()


  • Ventilator application software
tetraONE
Beckman Coulter, Inc.
6915050
In Commercial Distribution

  • 15099590572679 ()
6915050

  • Laboratory instrument/analyser application software IVD
stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution

  • 07290114064545 ()
407-000024-00

  • Depth electrode
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