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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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DreamStation BiPAP Pro with Humidifier, Canada
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, CA
In Commercial Distribution

  • 00606959026629 ()
CAX600H12

  • Home BPAP unit
DreamStation Auto CPAP with Humidifier, Canada
Respironics, Inc.
DreamStation Auto CPAP with Humidifier, CA
In Commercial Distribution

  • 00606959026599 ()
CAX500H12

  • Home CPAP unit
DreamStation CPAP Pro with Humidifier, Canada
Respironics, Inc.
DreamStation CPAP Pro with Humidifier, CA
In Commercial Distribution

  • 00606959026568 ()
CAX400H12

  • Home CPAP unit
DreamStation Auto BiPAP with Wifi, Canada
Respironics, Inc.
DreamStation Auto BiPAP w/WiFi, CA
In Commercial Distribution

  • 00606959034730 ()
CAX700S12W

  • Home BPAP unit
DreamStation Auto CPAP System with Wifi, Canada
Respironics, Inc.
DreamStation Auto CPAP w/WiFi, CA
In Commercial Distribution

  • 00606959034679 ()
CAX500S12W

  • Home CPAP unit
DreamStation Auto BiPAP with Cellular, Canada
Respironics, Inc.
DreamStation Auto BiPAP w/Cell, CA
In Commercial Distribution

  • 00606959034587 ()
CAX700S12C

  • Home BPAP unit
DreamStation Auto CPAP with Cellular, Canada
Respironics, Inc.
DreamStation Auto CPAP w/Cell, CA
In Commercial Distribution

  • 00606959034525 ()
CAX500S12C

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

  • 00606959031388 ()
CA661S

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

  • 00606959020061 ()
CA221S

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar Auto A-Flex, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto A-Flex, 60 Series, CA
In Commercial Distribution

  • 00606959014152 ()
CA561S

  • Home CPAP unit
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