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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 CPAP, USA
Respironics, Inc.
REMstar Pro, US
In Commercial Distribution

  • 00606959030107 ()
460P

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

  • 00606959030091 ()
267P

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

  • 00606959030084 ()
CA261NTS

  • Home CPAP unit
BiPAP AutoBiFlex with Heated Tube Humidifier, BlueTooth, System One 60 Series, AHP
Respironics, Inc.
BiPAP AutoBiFlex w/HTD Humid, BTooth, Sys One 60Srs, AHP
In Commercial Distribution

  • 00606959023994 ()
AH760TBT

  • Home BPAP unit
BiPAP Pro BiFlex with Heated Tube Humidifier, BlueTooth, System One 60 Series,AHP
Respironics, Inc.
BiPAP Pro BiFlex w/Htd Humid, BTooth, Sys One 60Srs, AHP
In Commercial Distribution

  • 00606959023963 ()
AH660TBT

  • Home BPAP unit
REMstar Pro with C-Flex+ System One 60 series CPAP System with Heated Tube Humidifier and Bluetooth (American Home Patient unit)
Respironics, Inc.
REMstar Pro C-Flex+, w/H Tube Humid, w/Btooth, 60 Srs, AHP
In Commercial Distribution

  • 00606959023901 ()
AH460TBT

  • Home CPAP unit
BiPAP Auto BiFlex, Brazil
Respironics, Inc.
BiPAP Auto BiFlex, BR
Not in Commercial Distribution

  • 00606959023291 ()
BR769S

  • Home BPAP unit
BiPAP Pro BiFlex, Brazil
Respironics, Inc.
BiPAP Pro BiFlex, BR
Not in Commercial Distribution

  • 00606959023284 ()
BR669S

  • Home BPAP unit
REMstar Auto A-Flex, Brazil
Respironics, Inc.
REMstar Auto A-Flex, BR
Not in Commercial Distribution

  • 00606959023277 ()
BR569S

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

  • 00606959039612 ()
557P

  • Home CPAP unit
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