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, 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
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 Expert with Humidifier, Heated Tubing, and Wifi for Canada
Respironics, Inc.
Dreamstation Expert w/Humid w/H Tube, w/WiFi, CA
In Commercial Distribution

  • 00606959053212 ()
CAX501T12W

  • Home CPAP unit
DreamStation Expert with Humidifier, Heated Tubing, and Cellular Modem for Canada
Respironics, Inc.
Dreamstation Expert w/Humid w/H Tube, w/Cell, CA
In Commercial Distribution

  • 00606959053205 ()
CAX501T12C

  • Home CPAP unit
BiPAP autoSV Advanced System One 60 Series with Heated Tube Humidifier, Canada
Respironics, Inc.
BiPAP autoSV Advanced w/H Tube Humid, 60 Series, CA
Not in Commercial Distribution

  • 00606959014237 ()
CA961TS

  • Portable electric ventilator
BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, Canada
Respironics, Inc.
BiPAP Auto BiFlex w/H Tube Humid, 60 Series, CA
In Commercial Distribution

  • 00606959014206 ()
CA761TS

  • Home BPAP unit
REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto A-Flex, w/H Tube Humid, 60 Series, CA
In Commercial Distribution

  • 00606959014169 ()
CA561TS

  • Home CPAP unit
REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, CA
In Commercial Distribution

  • 00606959014091 ()
CA461TS

  • Home CPAP unit
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