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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XT Fit with Humidifier
Wellell Inc.
9S-005500, 9S-006500
In Commercial Distribution

  • 14713025000025 ()
  • 04713025000028 ()


  • 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
DreamStation CPAP, International
Respironics, Inc.
DreamStation CPAP, International
Not in Commercial Distribution

  • 00606959060609 ()
INX219S15

  • Portable electric ventilator
  • Heated respiratory humidifier
Dorma 100, Oxigen Salud
Respironics, Inc.
Dorma 100, Oxigen Salud
In Commercial Distribution

  • 00606959021907 ()
XSV101

  • Home CPAP unit
  • Heated respiratory humidifier
REMstar SE with Heated Humidifier, Standard Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE w/HTD Humid, St Tube, with SD Slot, CA
In Commercial Distribution

  • 00606959020092 ()
CA221NTS

  • Home CPAP unit
  • Heated respiratory humidifier
REMstar SE with Heated Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, CA
Not in Commercial Distribution

  • 00606959020085 ()
CA221TS

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar SE with Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE with Humidifier, with SD Slot, CA
Not in Commercial Distribution

  • 00606959020078 ()
CA221HS

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar SE with SD Slot, Canada
Respironics, Inc.
REMstar SE with SD Slot, CA
Not in Commercial Distribution

  • 00606959020061 ()
CA221S

  • Heated respiratory humidifier
  • Home CPAP unit
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