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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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A40 ProEFL, System One Heated Tube Humidifier, France
Respironics, Inc.
FRX3T
In Commercial Distribution

  • 00606959058514 ()
FRX3T

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Tube Humidifier, Iberia
Respironics, Inc.
ESX3T
In Commercial Distribution

  • 00606959058507 ()
ESX3T

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Humidifier, United Kingdom
Respironics, Inc.
GBX3H
In Commercial Distribution

  • 00606959057906 ()
GBX3H

  • Heated respiratory humidifier
A Series, System One, Heated Tube Humidifier, FR
Respironics, Inc.
A Series, System One, Heated Tube Humidifier, FR
In Commercial Distribution

  • 00606959057869 ()
FR1111555

  • Heated respiratory humidifier
REMstar Auto A-Flex, System One 60 Series, GB
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, GB
In Commercial Distribution

  • 00606959030589 ()
GB561S

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

  • 00606959030336 ()
FI461S

  • Home CPAP unit
REMstar Pro C-Flex+, System One 60 Series, International
Respironics, Inc.
REMstar Pro C-Flex+, 60 Series, INTL
In Commercial Distribution

  • 00606959030251 ()
IN461S

  • Home CPAP unit
SOMNIA 3i C-Flex+, System One 60 Series, HL
Respironics, Inc.
SOMNIA 3i C-Flex+ System One 60 Series H&L
In Commercial Distribution

  • 00606959030244 ()
HL464S

  • Home CPAP unit
REMstar Plus C-Flex, System One 60 Series, GB
Respironics, Inc.
REMstar Plus C-Flex, System One 60 Series, GB
In Commercial Distribution

  • 00606959029941 ()
GB261S

  • Home CPAP unit
REMstar Plus C-Flex, System One 60 Series, International
Respironics, Inc.
REMstar Plus C-Flex, 60 Series, INTL
In Commercial Distribution

  • 00606959029880 ()
IN261S

  • Home CPAP unit
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