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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 C-Flex+, with Humidifier, System One 60 Series, ZA
Respironics, Inc.
REMstar Pro C-Flex+w/Hum, SysOne 60 Series, ZA
In Commercial Distribution

  • 00606959024984 ()
ZA461HS

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

  • 00606959023895 ()
AH460HBT

  • Home CPAP unit
BiPAP Auto BiFlex with Humdifier System One 60 Series,ND
Respironics, Inc.
BiPAP Auto BiFlex w/Hum Sys One 60 Series, ND
In Commercial Distribution

  • 00606959021853 ()
ND761HS

  • Home BPAP unit
BiPAP Pro BiFlex with Humidifier, System One 60 Series, ND
Respironics, Inc.
BiPAP Pro BiFlex w/Hum Sys One 60 Srs, ND
In Commercial Distribution

  • 00606959021839 ()
ND661HS

  • Home BPAP unit
REMstar Plus C-Flex, with Humidifier, System One 60 Series, ND
Respironics, Inc.
REMstar Plus CFlex, w/Hum Sys One 60 Srs, ND
In Commercial Distribution

  • 00606959021778 ()
ND261HS

  • Home CPAP unit
REMstar Pro C-Flex+, with Humidifier, System One 60 Series, China
Respironics, Inc.
REMstar Pro C-Flex+ w/ Humid, System One 60 Series, CN
Not in Commercial Distribution

  • 00606959015111 ()
CN467HS

  • Home CPAP unit
REMstar Plus C-Flex, with Humidifier, System One 60 Series, China
Respironics, Inc.
REMstar Plus C-Flex w/ Humid, System One 60 Series, CN
Not in Commercial Distribution

  • 00606959015081 ()
CN267HS

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

  • 00606959015050 ()
CN967HS

  • Portable electric ventilator
BiPAP Auto BiFlex with Humidifier System One 60 Series,Canada
Respironics, Inc.
BiPAP Auto BiFlex with Humidifier 60 Series, CA
In Commercial Distribution

  • 00606959031739 ()
CA761HS

  • Home BPAP unit
BiPAP Auto BiFlex with Humidifier System One 60 Series,ES
Respironics, Inc.
BiPAP Auto BiFlex with Humidifier System One 60 Series,ES
In Commercial Distribution

  • 00606959031685 ()
ES761HS

  • Home BPAP unit
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