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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Dorma 100 with Humidifier, International
Respironics, Inc.
Dorma 100 with Humidifier, INTL
In Commercial Distribution

  • 00606959006928 ()
INV101H

  • Heated respiratory humidifier
  • Home CPAP unit
Dorma 100, International
Respironics, Inc.
Dorma 100, INTL
In Commercial Distribution

  • 00606959006911 ()
INV101

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 500 Auto with Humidifier, Australia
Respironics, Inc.
Dorma 500 Auto with Humidifier, AU
In Commercial Distribution

  • 00606959049260 ()
AUV501H

  • Heated respiratory humidifier
  • Home CPAP unit
Dorma 500 Auto, Australia
Respironics, Inc.
Dorma 500 Auto, AU
In Commercial Distribution

  • 00606959049253 ()
AUV501

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 200, Italy
Respironics, Inc.
Dorma 200, IT
In Commercial Distribution

  • 00606959048287 ()
ITV201

  • Heated respiratory humidifier
  • Home CPAP unit
Dorma 100, Italy
Respironics, Inc.
Dorma 100, IT
In Commercial Distribution

  • 00606959048270 ()
ITV101

  • Home CPAP unit
  • Heated respiratory humidifier
XT Auto with Humidifier
Wellell Inc.
9S-005720, 9S-006500
In Commercial Distribution

  • 14713025000087 ()
  • 04713025000080 ()


  • Home CPAP unit
  • Heated respiratory humidifier
XT Prime with Humidifier
Wellell Inc.
9S-005580, 9S-006500
In Commercial Distribution

  • 14713025000063 ()
  • 04713025000066 ()


  • Home CPAP unit
  • Heated respiratory humidifier
XT Sense with Humidifier
Wellell Inc.
9S-005530, 9S-006500
In Commercial Distribution

  • 14713025000049 ()
  • 04713025000042 ()


  • Home CPAP unit
  • Heated respiratory humidifier
XT Fit with Humidifier
Wellell Inc.
9S-005500, 9S-006500
In Commercial Distribution

  • 14713025000025 ()
  • 04713025000028 ()


  • Home CPAP unit
  • Heated respiratory humidifier
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