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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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DreamStation Auto CPAP with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/Heated Tube, US
In Commercial Distribution

  • 00606959022485 ()
DSX500T11

  • Home CPAP unit
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 Heated Tube, with SD Slot, AH
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, AH
In Commercial Distribution

  • 00606959020054 ()
AH220TS

  • Heated respiratory humidifier
  • Home CPAP unit
DreamStation BiPAP autoSV with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation BiPAP autoSV w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959040564 ()
CAX900T12

  • Portable electric ventilator
DreamStation BiPAP autoSV with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation BiPAP autoSV w/Humidr w/H Tube, US
In Commercial Distribution

  • 00606959040533 ()
DSX900T11

  • Portable electric ventilator
Wisp Mask, with Fabric Frame, with Headgear, Large, International
Respironics, Inc.
Wisp Mask, Large, Fabric Frame, with Headgear, INTL
In Commercial Distribution

  • 00606959040076 ()
1094049

  • CPAP/BPAP nasal mask, reusable
Wisp Mask, with Clear Frame, with Headgear, Small-Medium, International
Respironics, Inc.
Wisp Mask, Small-Medium, Clear Frame, w/Headgear, INTL
In Commercial Distribution

  • 00606959040021 ()
1093924

  • CPAP/BPAP nasal mask, reusable
REMstar SE Auto with Humidifier, with SD Slot, Domestic
Respironics, Inc.
00
In Commercial Distribution

  • 00606959037083 ()
DS520HS

  • Home CPAP unit
  • Heated respiratory humidifier
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 Auto with Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto with Humidifier, with SD Slot, CA
In Commercial Distribution

  • 00606959036758 ()
CA521HS

  • Heated respiratory humidifier
  • Home CPAP unit
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