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 with Humidifier, System One 60 Series, Japan
Respironics, Inc.
REMstar Auto A-Flex w/Humid System One 60Series JP
Not in Commercial Distribution

  • 00606959030930 ()
JP566HS

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

  • 00606959030459 ()
JP466HS

  • Home CPAP unit
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, LARGE
Not in Commercial Distribution

  • 30606959028433 ()
  • 00606959028432 ()
1126377

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK, WITH STANDARD ELBOW WITH CAPSTRAP, MEDIUM, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, MEDIUM
Not in Commercial Distribution

  • 30606959028419 ()
  • 00606959028418 ()
1126375

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW WITH CAPSTRAP, SMALL, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JPN, SMALL
Not in Commercial Distribution

  • 30606959028396 ()
  • 00606959028395 ()
1126373

  • CPAP/BPAP face mask, single-use
DreamWisp Nasal, Extra Large with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, XL, S-M-L Connector w/Hdgr, JN
Not in Commercial Distribution

  • 00606959051195 ()
1137951

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Large with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, L, S-M-L Connector w/Hdgr, JN
In Commercial Distribution

  • 00606959051188 ()
1137950

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Medium with Small-Medium-Large Connector, With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, M, S-M-L Connector w/HDGR, JN
Not in Commercial Distribution

  • 00606959051171 ()
1137949

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Small with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, P, S-M-L Connector w/HDGR, JN
Not in Commercial Distribution

  • 00606959051164 ()
1137948

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Petite with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, P, S-M-L Connector w/Hdgr, JN
In Commercial Distribution

  • 00606959051157 ()
1137947

  • CPAP/BPAP nasal mask, reusable
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