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 Auto BiPAP with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, CA
In Commercial Distribution

  • 00606959026667 ()
CAX700T12

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

  • 00606959026605 ()
CAX500T12

  • Home CPAP 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 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
BiPAP autoSV Advanced with Humidifier, 60 Series, 30cm, CAN
Respironics, Inc.
BiPAP autoSV Advanced with Humidifier, 30cm, 60 Series, CA
Not in Commercial Distribution

  • 00606959029750 ()
CA961XHS

  • Portable electric ventilator
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
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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