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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 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 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
REMstar Plus C Flex, with Humidifier, System One 60 Series, SE
Respironics, Inc.
REMstar Plus C Flex, w/Humid, Sys One 60 Series, SE
In Commercial Distribution

  • 00606959029996 ()
SE261HS

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

  • 00606959029972 ()
FI261HS

  • Home CPAP unit
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 Plus C Flex, with Humidifier, System One 60 Series, International
Respironics, Inc.
REMstar Plus C-Flex, with Humidifier, 60 Series, INTL
Not in Commercial Distribution

  • 00606959029897 ()
IN261HS

  • Home CPAP unit
BiPAP autoSV Advanced System One 60 Series Ventilatory Support System, Germany
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, DE
Not in Commercial Distribution

  • 00606959029682 ()
DE962S

  • Portable electric ventilator
BiPAP autoSV Advanced System One 60 Series with Humidifier, Latin America
Respironics, Inc.
BiPAP autoSV Advanced with Humidifier, 60 Series, LA
Not in Commercial Distribution

  • 00606959029668 ()
LA961HS

  • Portable electric ventilator
BiPAP Auto BiFlex with Humidifier System One 60 Series, Latin America
Respironics, Inc.
BiPAP Auto BiFlex, w/Humid System One 60 Series LA
Not in Commercial Distribution

  • 00606959031579 ()
LA761HS

  • Home BPAP unit
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