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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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
DreamStation BiPAP autoSV with Humidifier, Canada
Respironics, Inc.
DreamStation BiPAP autoSV w/Humidifier, CA
In Commercial Distribution

  • 00606959040557 ()
CAX900H12

  • Portable electric ventilator
REMstar SE with SD Slot, Canada
Respironics, Inc.
REMstar SE with SD Slot, CA
In Commercial Distribution

  • 00606959038363 ()
221CA

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 500 Auto with Humidifier, Canada
Respironics, Inc.
Dorma 500 Auto with Humidifier, CA
In Commercial Distribution

  • 00606959036741 ()
CAV501H

  • Home CPAP unit
  • Heated respiratory humidifier
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
Millennium M10 Transfill, 120V, US, Canada
Respironics, Inc.
Millennium M10 Transfill,120V, US, CA
Not in Commercial Distribution

  • 00606959033207 ()
M10600-10

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

  • 00606959031722 ()
CA761S

  • Home BPAP unit
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