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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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REMstar SE with Heated Tube, with SD Slot, International
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, INTL
In Commercial Distribution

  • 00606959036925 ()
IN221TS

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar SE with Humidifier, with SD Slot, International
Respironics, Inc.
REMstar SE with HUMIDIFIER, with SD Slot, INTL
In Commercial Distribution

  • 00606959036918 ()
IN221HS

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 200 with Humidifier, International
Respironics, Inc.
Dorma 200, with Humidifier, INTL
In Commercial Distribution

  • 00606959036901 ()
INV201H

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

  • 00606959036895 ()
INV201

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar with Humidifier, International
Respironics, Inc.
REMstar, with Humidifier, INTL
Not in Commercial Distribution

  • 00606959036888 ()
IN171H

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar International
Respironics, Inc.
REMstar, INTL
Not in Commercial Distribution

  • 00606959036871 ()
IN171

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 500 Auto with Humidifier, India
Respironics, Inc.
Dorma 500 Auto, with Humidifier, IN
Not in Commercial Distribution

  • 00606959036864 ()
INDV501H

  • Heated respiratory humidifier
  • Home CPAP unit
Dorma 500 Auto, India
Respironics, Inc.
Dorma 500 Auto, IN
Not in Commercial Distribution

  • 00606959036857 ()
INDV501

  • Heated respiratory humidifier
  • Home CPAP unit
Dorma 500 Auto with Humidifier, Germany
Respironics, Inc.
00
In Commercial Distribution

  • 00606959036840 ()
DEV502H

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 500 Auto, Germany
Respironics, Inc.
Dorma 500 Auto, DE
Not in Commercial Distribution

  • 00606959036833 ()
DEV502

  • Home CPAP unit
  • Heated respiratory humidifier
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