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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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A40 ProEFL, System One Heated Tube Humidifier, United Kingdom
Respironics, Inc.
GBX3T
In Commercial Distribution

  • 00606959058491 ()
GBX3T

  • Heated respiratory humidifier
UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Red.
PHARMACEUTICAL INNOVATIONS INC
UltraWarmer Gel Warmer - Red
In Commercial Distribution

  • 10300361100034 ()
  • 00300361100037 ()
36-1100-03

  • Gel warmer
UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Navy.
PHARMACEUTICAL INNOVATIONS INC
UltraWarmer Gel Warmer - Navy
In Commercial Distribution

  • 10300361100027 ()
  • 00300361100020 ()
36-1100-02

  • Gel warmer
UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. White.
PHARMACEUTICAL INNOVATIONS INC
UltraWarmer Gel Warmer - White
In Commercial Distribution

  • 10300361100010 ()
  • 00300361100013 ()
36-1100-01

  • Gel warmer
REMstar Auto C-Flex+, BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto A-Flex, with BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959030558 ()
CA561BT

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

  • 00606959030282 ()
LA461S

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

  • 00606959030176 ()
CA461BT

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

  • 00606959030022 ()
PT261S

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

  • 00606959030008 ()
ES261S

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

  • 00606959029989 ()
SE261S

  • Home CPAP unit
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