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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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RESmart® Auto CPAP System with Integrated Heated Humidifier
BMC Medical Co., Ltd.
RESmart Auto (BMC-50)
In Commercial Distribution

  • 06948538363089 ()


  • Heated respiratory humidifier
  • Home CPAP unit
RESmart® CPAP System with Integrated Heated Humidifier
BMC Medical Co., Ltd.
RESmart (BMC-50)
In Commercial Distribution

  • 06948538363065 ()


  • Heated respiratory humidifier
  • Home CPAP unit
QinFlow portable warmer system - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body.The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 17290016740032 ()
QPORT1000U-1

  • Conduction blood/fluid warmer set
  • Conduction blood/fluid warmer
Warrior Lite Base Unit operated with a Rechargeable Lite Battery
QUALITY IN FLOW LTD
QIF-03
In Commercial Distribution

  • 37290016740166 ()


  • Conduction blood/fluid warmer
  • Portable/mobile rechargeable battery pack
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Heated
Carefusion Corporation
7166-HS7
Not in Commercial Distribution

  • 50885403171381 ()
  • 10885403171383 ()
7166-HS7

  • Ventilator breathing circuit, single-use
  • Straight/elbow breathing circuit connector, single-use
Airlife™ Adult Aerosol Mask with Misty Max 10™ Nebulizer
Carefusion Corporation
008299
Not in Commercial Distribution

  • 50885403169050 ()
  • 10885403169052 ()
008299

  • Aerosol face mask, non-rebreathing
  • Benchtop nebulizer, heated
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions.
INDIBA SA.
IDC0409
In Commercial Distribution

  • 08434251003084 ()
IDC0409USA

  • Medium-wave diathermy treatment system
EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
DiaDent Group International
BATTERY
In Commercial Distribution

  • 08806383555494 ()
4005-2050

  • Endodontic obturation system
EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
DiaDent Group International
DUAL CHARGER
In Commercial Distribution

  • 08806383554855 ()
4005-2020

  • Endodontic obturation system
EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
DiaDent Group International
EVOPACK HANDPIECE
In Commercial Distribution

  • 08806383554848 ()
4005-1201

  • Endodontic obturation system
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