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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 - 00606959031364

BiPAP Pro BiFlex with Humidifier System One 60 Series, PT
Respironics, Inc.
BiPAP Pro BiFlex, w/Humidifer, System One 60 Series,PT
In Commercial Distribution

  • 00606959031364 ()
PT661HS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959031340

BiPAP Pro BiFlex with Humidifier, System One 60 Series, ES
Respironics, Inc.
BiPAP Pro BiFlex with Humidifier, System One 60 Series, ES
In Commercial Distribution

  • 00606959031340 ()
ES661HS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959031326

BiPAP Pro BiFlex with Humidifier, System One 60 Series, NO
Respironics, Inc.
BiPAP Pro BiFlex w/Humidifier, Sys One 60 Series, NO
In Commercial Distribution

  • 00606959031326 ()
NO661HS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959031302

BiPAP Pro BiFlex with Humidifier, System One 60 Series, SE
Respironics, Inc.
BiPAP Pro BiFlex, w/Humidifier, System One 60 Series, SE
In Commercial Distribution

  • 00606959031302 ()
SE661HS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959031289

BiPAP Pro BiFlex with Humidifier, System One 60 Series, FI
Respironics, Inc.
BiPAP Pro BiFlex with Humidifier, System One 60 Series, FI
In Commercial Distribution

  • 00606959031289 ()
FI661HS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959031265

BiPAP Pro BiFlex with Humidifier, System One 60 Series, GB
Respironics, Inc.
BiPAP Pro BiFlex, with Humidifier, System One 60 Srs,GB
In Commercial Distribution

  • 00606959031265 ()
GB661HS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959031203

BiPAP Pro BiFlex, with Humidifier, System One 60 Series, International
Respironics, Inc.
BiPAP Pro BiFlex, w/Humid System One 60 Series INT
In Commercial Distribution

  • 00606959031203 ()
IN661HS

  • Home BPAP unit

BiPAP System One 60 Series - 00606959031029

BiPAP Pro C-Flex+ Humidifier, BlueTooth, System One 60 Series, USA
Respironics, Inc.
BiPAP Pro Bi-Flex w/ Humid, BTOOTH Sys One 60 Srs, US
In Commercial Distribution

  • 00606959031029 ()
DS660HBT

  • Home BPAP unit

REMstar System One 60 Series - 00606959030985

REMstar Auto P-Flex, with Humidifier, System One 60 Series, France
Respironics, Inc.
REMstar Auto P-Flex, w/Humid, Sys One 60 Srs, FR
In Commercial Distribution

  • 00606959030985 ()
FR568HS

  • Home CPAP unit

REMstar System One 60 Series - 00606959030930

REMstar Auto A-Flex with Humidifier, System One 60 Series, Japan
Respironics, Inc.
REMstar Auto A-Flex w/Humid System One 60Series JP
Not in Commercial Distribution

  • 00606959030930 ()
JP566HS

  • Home CPAP unit
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