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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BiPAP Auto BiFlex with Humidifier System One 60 Series,Canada
Respironics, Inc.
BiPAP Auto BiFlex with Humidifier 60 Series, CA
In Commercial Distribution

  • 00606959031739 ()
CA761HS

  • Home BPAP unit
BiPAP Pro BiFlex System One 60 Series BiPAP System with BlueTooth, Canada
Respironics, Inc.
BiPAP Pro BiFlex+, with BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959031425 ()
CA661BT

  • Home BPAP unit
DreamStation, CPAP with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation CPAP w/Humidifier, w/Heated Tube, CA
In Commercial Distribution

  • 00606959026544 ()
CAX200T12

  • Home CPAP unit
EverFlo Domestic OPI 120V - US, Canada
Respironics, Inc.
EVERFLO w/Oxygen Percentage Indicator, 120V US, CA
In Commercial Distribution

  • 00606959022041 ()
1020001

  • Stationary oxygen concentrator
DreamStation BiPAP AVAPS30 with Humidifier, with Cell Modem, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CA
In Commercial Distribution

  • 00606959045712 ()
CAX1130H12C

  • Portable electric ventilator
DreamStation BiPAP AVAPS30 AAM with Humidifier, with WiFi, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CA
In Commercial Distribution

  • 00606959045682 ()
CAX1130H12W

  • Portable electric ventilator
REMstar Auto C-Flex+ with Humidifier, BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto C-Flex+ w/Humid, BlueTooth, 60 Srs, CA
In Commercial Distribution

  • 00606959030565 ()
CA561HBT

  • Home CPAP unit
REMstar SE with Heated Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, CA
Not in Commercial Distribution

  • 00606959020085 ()
CA221TS

  • Heated respiratory humidifier
  • Home CPAP unit
DreamStation BiPAP autoSV with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation BiPAP autoSV w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959040564 ()
CAX900T12

  • Portable electric ventilator
REMstar Auto with Heated Humidifier, with BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto w/HTD Humid, BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959037762 ()
CA561TBT

  • Home CPAP unit
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