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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 BiFlex System One 60 Series BiPAP System with BlueTooth, Canada
Respironics, Inc.
BiPAP Pro BiFlex+, with BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959031425 ()
CA661BT

  • Home BPAP unit
BiPAP Pro, Canada
Respironics, Inc.
BiPAP Pro, CA
In Commercial Distribution

  • 00606959031371 ()
661CA

  • Home BPAP unit
REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, International
Respironics, Inc.
REMstar Auto A-Flex, w/H Tube Humid, 60 Series, INTL
In Commercial Distribution

  • 00606959030770 ()
IN561TS

  • Home CPAP unit
REMstar Auto, International
Respironics, Inc.
REMstar Auto, INTL
In Commercial Distribution

  • 00606959030572 ()
561P

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

  • 00606959030534 ()
CA561NTS

  • Home CPAP unit
REMstar Pro C-Flex+, with Heated Tube Humidifier, Standard Tube, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, w/H Tube Humid, w/St Tube, 60 Srs, CA
In Commercial Distribution

  • 00606959030152 ()
CA461NTS

  • Home CPAP unit
REMstar Pro C-Flex+, Heated Tube Humidifier, BlueTooth, System One 60 Series, USA
Respironics, Inc.
REMstar Pro C-Flex+ w/HT Humid, BTOOTH Sys One 60 Srs, US
In Commercial Distribution

  • 00606959030121 ()
DS460TBT

  • Home CPAP unit
REMStar Pro, with BlueTooth, USA
Respironics, Inc.
REMStar Pro, w/BlueTooth, US
In Commercial Distribution

  • 00606959030114 ()
460PBT

  • Home CPAP unit
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
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