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
In Commercial Distribution

  • 00606959038363 ()
221CA

  • Home CPAP unit
  • Heated respiratory humidifier
DreamStation WiFi with Oximetry, Canada
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, CA
In Commercial Distribution

  • 00606959037533 ()
200710W

  • Medical networking interface unit
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
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
DreamStation BiPAP Pro with Humidifier, Canada
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, CA
In Commercial Distribution

  • 00606959026629 ()
CAX600H12

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

  • 00606959026568 ()
CAX400H12

  • 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
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 Pelvic Positioner Kit With2 Pads And 2 Post Protector Caps Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49482
In Commercial Distribution

  • 20885632448642 ()
  • 10885632448645 ()


  • Freestanding patient positioner, single-use
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