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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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SOMNIA 3i C-Flex+, System One 60 Series, HL
Respironics, Inc.
SOMNIA 3i C-Flex+ System One 60 Series H&L
In Commercial Distribution

  • 00606959030244 ()
HL464S

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

  • 00606959029941 ()
GB261S

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

  • 00606959029880 ()
IN261S

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

  • 00606959029620 ()
IN961S

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

  • 00606959029606 ()
CA961S

  • Portable electric ventilator
REMstar Auto A-Flex, System One 60 Series, ZA
Respironics, Inc.
00
In Commercial Distribution

  • 00606959024991 ()
ZA561S

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

  • 00606959024977 ()
ZA461S

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

  • 00606959031814 ()
DE762S

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

  • 00606959031722 ()
CA761S

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

  • 00606959031692 ()
PT761S

  • Home BPAP unit
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