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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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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
Airlife™ Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Heated
Carefusion Corporation
10195-HS3
Not in Commercial Distribution

  • 50885403026575 ()
  • 10885403026577 ()
10195-HS3

  • Airway pressure monitor, non-powered
  • Ventilator breathing circuit, single-use
Prone Breast System, complete set with Carbon Fiber Baseplate, 2 contralateral cushions, 2 ProneHead Supports and baseplate, Lateral Head Support, 2 Wedge AccuCushions, and Upper Vacuum Bag.
Klarity Medical Products, LLC
R6400-CF
In Commercial Distribution

  • 00817355023079 ()


  • Patient positioning thermoplastic mould material
  • Indexed-immobilization patient positioning system
QinFlow Warrior Extreme system kit - 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 kit contains 1 battery. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
QIF-01-12 kit
In Commercial Distribution

  • 07290016740080 ()
Q1210S0000U

  • Conduction blood/fluid warmer
  • Conduction blood/fluid warmer set
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
Luna® CPAP System with Integrated Heated Humidifier
BMC Medical Co., Ltd.
E-20C-H-O(H60)
In Commercial Distribution

  • 06948538363126 ()


  • Heated respiratory humidifier
  • Home CPAP unit
Luna® Auto CPAP System with Integrated Heated Humidifier
BMC Medical Co., Ltd.
E-20AJ-H-O(H60)
In Commercial Distribution

  • 06948538363119 ()


  • Heated respiratory humidifier
  • Home CPAP unit
Luna® Auto CPAP System with Integrated Heated Humidifier
BMC Medical Co., Ltd.
E-20A-H-O(H60)
In Commercial Distribution

  • 06948538363102 ()


  • Heated respiratory humidifier
  • Home CPAP unit
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
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