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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 - 00606959022485

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 - 00606959020085

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 - 00606959020054

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 - 00606959040564

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 - 00606959040533

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 - 00606959040076

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 - 00606959040021

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 - 00606959037083

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 - 00606959036925

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 - 00606959036758

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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