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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, PT
Respironics, Inc.
BiPAP Pro BiFlex, Sys One 60 Srs, PT
In Commercial Distribution

  • 00606959031357 ()
PT661S

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

  • 00606959031333 ()
ES661S

  • Home BPAP unit
BiPAP Pro BiFlex, System One 60 Series, NO
Respironics, Inc.
BiPAP Pro BiFlex, System One 60 Series, NO
In Commercial Distribution

  • 00606959031319 ()
NO661S

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

  • 00606959031296 ()
SE661S

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

  • 00606959031272 ()
FI661S

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

  • 00606959031258 ()
GB661S

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

  • 00606959031197 ()
IN661S

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

  • 00606959030978 ()
FR568S

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

  • 00606959030794 ()
LA561S

  • Home CPAP unit
REMstar Auto A-Flex System One 60 Series, International
Respironics, Inc.
REMstar Auto A-Flex, 60 Series, INTL
In Commercial Distribution

  • 00606959030756 ()
IN561S

  • Home CPAP unit
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