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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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REMstar Plus C-Flex, with Humidifier, System One 60 Series, China
Respironics, Inc.
REMstar Plus C-Flex w/ Humid, System One 60 Series, CN
Not in Commercial Distribution

  • 00606959015081 ()
CN267HS

  • Home CPAP unit
BiPAP autoSV Advanced with Humidifier, System One 60 Series, China
Respironics, Inc.
BiPAP autoSV Advanced with Humidifier, 60 Series, CN
Not in Commercial Distribution

  • 00606959015050 ()
CN967HS

  • 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 Auto BiFlex with Humidifier System One 60 Series,ES
Respironics, Inc.
BiPAP Auto BiFlex with Humidifier System One 60 Series,ES
In Commercial Distribution

  • 00606959031685 ()
ES761HS

  • Home BPAP unit
BiPAP Auto BiFlex with Humidifier, System One 60 Series,NO
Respironics, Inc.
BiPAP Auto BiFlex with Humidifier, System One 60 Series,NO
In Commercial Distribution

  • 00606959031661 ()
NO761HS

  • Home BPAP unit
BiPAP Auto BiFlex with Humidifier System One 60 Series,SE
Respironics, Inc.
BiPAP Auto BiFlex, with Humidifier, System One 60 Series, SE
In Commercial Distribution

  • 00606959031647 ()
SE761HS

  • Home BPAP unit
BiPAP Auto BiFlex with Humidifier System One 60 Series,GB
Respironics, Inc.
BiPAP Auto BiFlex w/Humidifier System One 60 Series,GB
In Commercial Distribution

  • 00606959031609 ()
GB761HS

  • Home BPAP unit
BiPAP Pro BiFlex with Humidifier, System One 60 Series, ES
Respironics, Inc.
BiPAP Pro BiFlex with Humidifier, System One 60 Series, ES
In Commercial Distribution

  • 00606959031340 ()
ES661HS

  • Home BPAP unit
BiPAP Pro BiFlex with Humidifier, System One 60 Series, NO
Respironics, Inc.
BiPAP Pro BiFlex w/Humidifier, Sys One 60 Series, NO
In Commercial Distribution

  • 00606959031326 ()
NO661HS

  • Home BPAP unit
BiPAP Pro BiFlex with Humidifier, System One 60 Series, SE
Respironics, Inc.
BiPAP Pro BiFlex, w/Humidifier, System One 60 Series, SE
In Commercial Distribution

  • 00606959031302 ()
SE661HS

  • Home BPAP unit
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