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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 Auto A-Flex, with Humidifier, System One 60 Series, LA
Respironics, Inc.
REMstar Auto A-Flex, w/Humid System One 60 Series LA
Not in Commercial Distribution

  • 00606959030800 ()
LA561HS

  • Home CPAP unit
REMstar Auto A-Flex, with Humidifier System One 60 Series, International
Respironics, Inc.
REMstar Auto A-Flex, with Humidifier, 60 Series, INTL
In Commercial Distribution

  • 00606959030763 ()
IN561HS

  • Home CPAP unit
REMstar Auto A-Flex, with Humidifier, System One 60 Series, GB
Respironics, Inc.
REMstar Auto A-Flex, w/Humid, System One 60 Srs, GB
In Commercial Distribution

  • 00606959030596 ()
GB561HS

  • Home CPAP unit
REMstar Pro C-Flex+, wiith Humidifer, System One 60 Series, PT
Respironics, Inc.
REMstar Pro C-Flex+, w/Humid, System One 60 Srs, PT
In Commercial Distribution

  • 00606959030404 ()
PT461HS

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

  • 00606959030381 ()
ES461HS

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

  • 00606959030367 ()
SE461HS

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

  • 00606959030343 ()
FI461HS

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

  • 00606959029729 ()
FR965HS

  • Portable electric ventilator
BiPAP autoSV Advanced System One 60 Series with Humidifier, Germany
Respironics, Inc.
BiPAP autoSV Advanced, with Humidifier, 60 Series, DE
In Commercial Distribution

  • 00606959029699 ()
DE962HS

  • Portable electric ventilator
BiPAP autoSV Advanced System One 60 Series with Humidifier, International
Respironics, Inc.
BiPAP autoSV Advanced w/ Humidifier, 60 Series, INTL
In Commercial Distribution

  • 00606959029637 ()
IN961HS

  • Portable electric ventilator
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