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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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 SE Auto with Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto with Humidifier, with SD Slot, CA
In Commercial Distribution

  • 00606959036758 ()
CA521HS

  • Heated respiratory humidifier
  • Home CPAP unit
EVERFLO QUIET w/O2 Percent Indicator, 120V, US, Canada
Respironics, Inc.
EVERFLO QUIET w/O2 Percent Indicator, 120V, US, CA
In Commercial Distribution

  • 00606959032620 ()
1020014

  • Stationary oxygen concentrator
DreamStation BiPAP Pro with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959026636 ()
CAX600T12

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

  • 00606959026575 ()
CAX400T12

  • 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
Millennium M10 O2 Percent Indicator, Transfill,120V, US/CANADA
Respironics, Inc.
Millennium M10 O2 Percent Ind, Transfill,120V, US/CA
Not in Commercial Distribution

  • 00606959012776 ()
M10605-10

  • Stationary oxygen concentrator
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
BiPAP Auto BiFlex Humidifier, BlueTooth, System One 60 Series,Canada
Respironics, Inc.
BiPAP Auto BiFlex w/ Humidifier, BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959031777 ()
CA761HBT

  • Home BPAP unit
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
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