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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 System One 60 Series - 00606959005518

BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, AUS
Respironics, Inc.
BiPAP Auto BiFlex, w/HTD Humid, Sys One 60Srs, AU
Not in Commercial Distribution

  • 00606959005518 ()
AU761TS

  • Home BPAP unit

REMstar System One 60 Series - 00606959005877

REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, AHP
Respironics, Inc.
REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AHP
In Commercial Distribution

  • 00606959005877 ()
AH560TS

  • Home CPAP unit

REMstar System One 60 Series - 00606959005815

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

  • 00606959005815 ()
AH460TS

  • Home CPAP unit

REMstar System One 60 Series - 00606959005488

REMstar Auto A-Flex System One 60 series CPAP System with Heated Tube Humidifier, Australia
Respironics, Inc.
REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AU
In Commercial Distribution

  • 00606959005488 ()
AU561TS

  • Home CPAP unit

REMstar System One 60 Series - 00606959005457

REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Australia
Respironics, Inc.
REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, AU
In Commercial Distribution

  • 00606959005457 ()
AU461TS

  • Home CPAP unit

REMstar System One 50 Series - 00606959001046

REMstar Auto A-Flex with Humidifier, with SD Card, China
Respironics, Inc.
REMstar Auto A-Flex with Humidifier, with SD Card, China
Not in Commercial Distribution

  • 00606959001046 ()
CN557HS

  • Home CPAP unit

BiPAP System One 60 Series - 00606959014350

BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, China
Respironics, Inc.
BiPAP Auto BiFlex, w/HT Humid System One 60 Series, CN
Not in Commercial Distribution

  • 00606959014350 ()
CN767TS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959014329

BiPAP Pro BiFlex with Heated Tube Humidifier, System One 60 Series, China
Respironics, Inc.
BiPAP Pro BiFlex, w/HT Humid System One 60 Series, CN
Not in Commercial Distribution

  • 00606959014329 ()
CN667TS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959014206

BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, Canada
Respironics, Inc.
BiPAP Auto BiFlex w/H Tube Humid, 60 Series, CA
In Commercial Distribution

  • 00606959014206 ()
CA761TS

  • Home BPAP unit

REMstar System One 60 Series - 00606959014169

REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto A-Flex, w/H Tube Humid, 60 Series, CA
In Commercial Distribution

  • 00606959014169 ()
CA561TS

  • Home CPAP unit
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