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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, 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
REMstar Auto A-Flex System One 60 Series, FR
Respironics, Inc.
REMstar Auto A-Flex System One 60 Series FR
Not in Commercial Distribution

  • 00606959030725 ()
FR565S

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

  • 00606959030695 ()
PT561S

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

  • 00606959030664 ()
ES561S

  • Home CPAP unit
REMstar auto A-Flex, System One 60 Series, NO
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, NO
In Commercial Distribution

  • 00606959030657 ()
NO561S

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

  • 00606959030626 ()
SE561S

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

  • 00606959030602 ()
FI561S

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

  • 00606959030503 ()
DE562S

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

  • 00606959030466 ()
JP466S

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

  • 00606959030411 ()
FR465S

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

  • 00606959030398 ()
PT461S

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

  • 00606959030374 ()
ES461S

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

  • 00606959030350 ()
SE461S

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

  • 00606959030329 ()
GB461S

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

  • 00606959030237 ()
FR365S

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

  • 00606959030220 ()
DE462S

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

  • 00606959030145 ()
CA461S

  • Home CPAP unit
BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, JP
Not in Commercial Distribution

  • 00606959029743 ()
JP966S

  • Portable electric ventilator
BiPAP autoSV Advanced System One 60 Series, France
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, FR
Not in Commercial Distribution

  • 00606959029712 ()
FR965S

  • Portable electric ventilator
A Series System One Heated Tube Humidifier, US
Respironics, Inc.
A Series System One Heated Tube Humidifier, US
In Commercial Distribution

  • 00606959039636 ()
1111554

  • Heated respiratory humidifier
BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, JP
Not in Commercial Distribution

  • 00606959038202 ()
966P

  • Portable electric ventilator
BiPAP autoSV Advanced System One 60 Series, Germany
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, DE
In Commercial Distribution

  • 00606959038196 ()
962P

  • Portable electric ventilator
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