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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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Philips Sonicare - 08710103988977

Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush

BD Pyxis - 10885403513800

BD Pyxis MedBank Tower (Cabinet CR Software v3.X)
CAREFUSION 303, INC.
SW-MB-CR-V3
In Commercial Distribution

  • 10885403513800 ()


  • Anaesthesia cabinet

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

Ivenix Infusion System - 00811505030436

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-07
In Commercial Distribution

  • 00811505030436 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811505030375

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
In Commercial Distribution

  • 00811505030375 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811505030467

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-08
In Commercial Distribution

  • 00811505030467 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811050530375

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
Not in Commercial Distribution

  • 00811050530375 ()
LVP-SW

  • Bedside infusion pump, single-channel

Synergy E - B036101483

Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor

SOZOpro - B277SOZOPRO0

Application- Bio-Impendence Analysis software used for determining Body Composition
IMPEDIMED LIMITED
1.1.0
Not in Commercial Distribution

  • B277SOZOPRO0 ()
SOZOpro

  • Bioelectrical body composition analyser

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor - 00817980021396

EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software
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