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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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BiPAP Pro, International
Respironics, Inc.
BiPAP Pro, INTL
In Commercial Distribution

  • 00606959031180 ()
661P

  • Home BPAP unit
BiPAP Pro C-Flex+, with Heated Tube Humidifier, with BlueTooth, System One 60 Series, USA
Respironics, Inc.
BiPAP Pro C-Flex+ HTHum,BT,SystemOne, 60Series, US
In Commercial Distribution

  • 00606959031173 ()
DS660TBT

  • Home BPAP unit
BiPAP Pro, USA
Respironics, Inc.
BiPAP Pro, US
In Commercial Distribution

  • 00606959031166 ()
660P

  • Home BPAP unit
REMstar Auto P-Flex, France
Respironics, Inc.
REMstar Auto P-Flex, FR
In Commercial Distribution

  • 00606959031159 ()
568P

  • Home CPAP unit
REMstar Auto, China
Respironics, Inc.
REMstar Auto, CN
Not in Commercial Distribution

  • 00606959031142 ()
567P

  • Home CPAP unit
BiPAP Pro BlueTooth, USA
Respironics, Inc.
BiPAP Pro BlueTooth, US
In Commercial Distribution

  • 00606959031005 ()
660PBT

  • Home BPAP unit
REMstar Auto P-Flex, with Heated Tube Humidifier, System One 60 Series, France
Respironics, Inc.
REMstar Auto P-Flex, w/H Tube Humid, Sys One 60 Series, FR
In Commercial Distribution

  • 00606959030992 ()
FR568TS

  • Home CPAP unit
REMstar Auto A-Flex with Heated Tube Humidifier System One 60 Series, Japan
Respironics, Inc.
REMstar Auto A-Flex w/HT Humid System One 60 Series JP
Not in Commercial Distribution

  • 00606959030954 ()
JP566TS

  • Home CPAP unit
REMstar Auto A-Flex with SD Card, Japan
Respironics, Inc.
REMstar Auto A-Flex W/SD Card JP
Not in Commercial Distribution

  • 00606959030923 ()
JP566S

  • Home CPAP unit
REMstar Auto, Japan
Respironics, Inc.
REMstar Auto JP
Not in Commercial Distribution

  • 00606959030831 ()
566P

  • Home CPAP unit
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