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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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No Description
MICROLIFE USA, INC.
BP3MX1-3
In Commercial Distribution

  • 16970388169167 ()
  • 06970388169160 ()
  • 26970388169164 ()


  • Arrythmia-detection sphygmomanometer
Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
ASCOM UMS SRL
SW000754
In Commercial Distribution

  • 17350097870032 ()


  • Alarm application software
No Description
Ascom (Sweden) AB
Unite Connect for Clinical Systems
In Commercial Distribution

  • 17350088671273 ()
SW000466

  • Alarm application software
No Description
Ascom (Sweden) AB
Cardiomax
In Commercial Distribution

  • 17350088670016 ()
SW000466

  • Alarm application software
No Description
Ascom (Sweden) AB
Mobile Monitoring Gateway (MMG)
In Commercial Distribution

  • 17350088670009 ()
SW000400

  • Alarm application software
No Description
Beijing ADSS Development Co., Ltd.
PDT-FACE
In Commercial Distribution

  • 06970453270005 ()


  • Red/blue light phototherapy unit
MiVu Balloon
DIVERSATEK HEALTHCARE, INC.
MI-BAL-01
In Commercial Distribution

  • 00816734022481 ()

  • Balloon Diameter: 20 Millimeter
MI-BAL-01

  • Manometric gastrointestinal motility analysis system
SureSigns VS2+ NBP/SP02/Wireless
Philips Medical Systems Hsg
863279
In Commercial Distribution

  • 00884838028401 ()
863279

  • General-purpose multi-parameter bedside monitor
Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
40009
In Commercial Distribution

  • 00856571007104 ()
40009

  • Virtual bronchoscopic navigation PACS software
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software
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