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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 Auto A-Flex System One 60 Series, Argentina
Respironics, Inc.
REMstar Auto A-Flex, 60 Series, AR
In Commercial Distribution

  • 00606959048300 ()
AR561S

  • Home CPAP unit
REMstar Pro C-Flex+, System One 60 Series, Argentina
Respironics, Inc.
REMstar Pro C-Flex+, 60 Series, AR
In Commercial Distribution

  • 00606959048294 ()
AR461S

  • Home CPAP unit
BiPAP autoSV Advanced System One 60 Series, Italy
Respironics, Inc.
BiPAP autoSV Advanced 60 Series, IT
In Commercial Distribution

  • 00606959048263 ()
IT961S

  • Portable electric ventilator
BiPAP Auto BiFlex, System One 60 Series, italy
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, Italy
In Commercial Distribution

  • 00606959048256 ()
IT761S

  • Home BPAP unit
REMstar Auto A-Flex System One 60 Series, Italy
Respironics, Inc.
REMstar Auto A-Flex System One 60 Series, Italy
Not in Commercial Distribution

  • 00606959048225 ()
IT561S

  • Home CPAP unit
REMstar Pro C-Flex+, System One 60 Series, Italy
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, Italy
Not in Commercial Distribution

  • 00606959048218 ()
IT461S

  • Home CPAP unit
BiPAP Auto BiFlex, System One 60 Series, USA
Respironics, Inc.
BiPAP Auto BiFlex System One 60 Series,US
Not in Commercial Distribution

  • 00606959006003 ()
DS760S

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

  • 00606959005976 ()
AH760S

  • Home BPAP unit
,BiPAP Pro BiFlex, System One 60 Series, USA
Respironics, Inc.
BiPAP Pro BiFlex System One 60 Series US
In Commercial Distribution

  • 00606959005945 ()
DS660S

  • Home BPAP unit
BiPAP Pro BiFlex, System One 60 Series, AHP
Respironics, Inc.
BiPAP Pro BiFlex, System One 60 Series, AHP
In Commercial Distribution

  • 00606959005914 ()
AH660S

  • Home BPAP unit
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