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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 Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Kit
In Commercial Distribution

  • 00862290000333 ()


  • Cognitive assessment software
SS Roller Board Rack is designed to hold patient transfer roller boards on the wall. This keeps the roller boards clean and off the floor, protects them from damage, and stores them at the point of use so they are always right where you need them, when you need them. Constructed of stainless steel with no seams or cavities makes them easy to clean and disinfect. Hardware is not included, due to varying substrates in medical facilities.
MID CENTRAL MEDICAL CORP.
MCM132
In Commercial Distribution

  • 10810030860102 ()

  • Length: 9 Inch
  • Height: 2 Inch
  • Depth: 1.75 Inch
MCM132

  • Patient position turntable
The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessment ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value
NORAV MEDICAL LTD.
PCECG 1200W
In Commercial Distribution

  • 07290110250485 ()


  • Electrocardiography telemetric monitoring system transmitter
The Digi-Lite IP color flow imaging system is an ultrasound based system intended for use in non-invasive vascular evaluation for carotid (extracranial diagnosis), peripheral nerves and musculoskeletal in adults and in children. The Digi Lite IP only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Digi Lite IP via USB 2.0. Minimum requirements are given for the PC. The Linear probe is connected to the Digi Lite IP.
RIMED LTD.
Digi-Lite IP
In Commercial Distribution

  • 07290016734010 ()
400001

  • General-purpose ultrasound imaging system
TL-6800 Auto lensmeter Hartmann sensor with 145 measurement points, ensures better result for progressive and multi-focus recognition and more accurate results Green spectral measurement light source Higher level hardware, good tracing performance of the optical system and faster measurement speed Can measure lens of low transmittance rate no less than 5% , sun glasses with dark color, tinted lens and polarized lens UV measurement Humanized design, tiltable screen, comfortable operation and easier for observation Data can be transferred to auto phoropter
Ningbo Ming Sing Optical R & D Co., Ltd.
TL-6800
In Commercial Distribution

  • 06971821408020 ()


  • Manually-adjusted lensmeter, line-powered
Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware.
Philips Medizin Systeme Böblingen GmbH
Expression MR400 MRI Patient Monitor Sys
In Commercial Distribution

  • 00884838111363 ()
866185

  • General-purpose multi-parameter bedside monitor
Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware.
Philips Ds North America LLC
Expression MR400 MRI Patient Monitor Sys
Not in Commercial Distribution

  • 00884838039131 ()
866185

  • General-purpose multi-parameter bedside monitor
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.2
In Commercial Distribution

  • 00884838093997 ()
45980163324X

  • Radiology picture archiving and communication system workstation
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.x
In Commercial Distribution

  • 00884838087958 ()
45980141116X

  • Radiology picture archiving and communication system workstation
IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography.
Philips Healthcare Informatics, Inc.
IntelliSpace Radiology - 4
In Commercial Distribution

  • 00884838091740 ()
836344

  • Radiology picture archiving and communication system workstation
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