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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, Latin America
Respironics, Inc.
REMstar Plus C-Flex, w/Humid, Sys One 60 Series, LA
Not in Commercial Distribution

  • 00606959029927 ()
LA261HS

  • Home CPAP unit
REMstar Auto C-Flex+ with Humidifier, BlueTooth, System One 60 Series, USA
Respironics, Inc.
REMstar Auto A-Flex w/ Humid, BTOOTH Sys One 60 Srs, US
In Commercial Distribution

  • 00606959024212 ()
DS560HBT

  • Home CPAP unit
REMstar Pro C-Flex+, with Humidifier, BlueTooth, System One 60 Series, USA
Respironics, Inc.
REMstar Pro C-Flex+ w/ Humid, BTOOTH Sys One 60 Srs, US
In Commercial Distribution

  • 00606959024199 ()
DS460HBT

  • Home CPAP unit
BiPAP Pro BiFlex with Humidifer, BlueTooth, System One, 60 Series,Canada
Respironics, Inc.
BiPAP Pro BiFlex+, w/Humid, w/BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959031432 ()
CA661HBT

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

  • 00606959031388 ()
CA661S

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

  • 00606959030565 ()
CA561HBT

  • Home CPAP unit
REMstar Pro C-Flex+, with Humidifier, System One 60 Series, Latin America
Respironics, Inc.
REMstar Pro C-Flex+, w/Humid System One 60 Series LA
Not in Commercial Distribution

  • 00606959030299 ()
LA461HS

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

  • 00606959030077 ()
CA261TS

  • Home CPAP unit
REMstar Plus C Flex, with Humidifier, System One 60 Series, PT
Respironics, Inc.
REMstar Plus C Flex, w/Humid, System One 60 Series, PT
In Commercial Distribution

  • 00606959030039 ()
PT261HS

  • Home CPAP unit
REMstar Plus C Flex, with Humidifier, System One 60 Series, Spain
Respironics, Inc.
REMstar Plus C Flex, w/Humid, System One 60 Series, ES
In Commercial Distribution

  • 00606959030015 ()
ES261HS

  • Home CPAP unit
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