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 Pro C-Flex+, BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, with BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959030176 ()
CA461BT

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

  • 00606959034532 ()
CAX500H12C

  • Heated respiratory humidifier
EVERFLO QUIET, NON-O2 Percent Indicator, 120V, US, Canada
Respironics, Inc.
EVERFLO QUIET, NON-O2 Percent Indicator, 120V, US, CA
In Commercial Distribution

  • 00606959032637 ()
1020015

  • Stationary oxygen concentrator
BiPAP autoSV Advanced Ventilatory Support System One 60 Series, Canada
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, CA
In Commercial Distribution

  • 00606959031982 ()
961CA

  • Portable electric ventilator
BiPAP Auto BiFlex with Humidifier System One 60 Series,Canada
Respironics, Inc.
BiPAP Auto BiFlex with Humidifier 60 Series, CA
In Commercial Distribution

  • 00606959031739 ()
CA761HS

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

  • 00606959031425 ()
CA661BT

  • Home BPAP unit
REMstar Auto C-Flex+, BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto A-Flex, with BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959030558 ()
CA561BT

  • Home CPAP unit
EverFlo Domestic OPI 120V - US, Canada
Respironics, Inc.
EVERFLO w/Oxygen Percentage Indicator, 120V US, CA
In Commercial Distribution

  • 00606959022041 ()
1020001

  • Stationary oxygen concentrator
REMstar Auto A-Flex with Humidifier, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto A-Flex with Humidifier, 60 Series, CA
In Commercial Distribution

  • 00606959014145 ()
CA561HS

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

  • 00606959026544 ()
CAX200T12

  • Home CPAP unit
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