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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 - 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

DreamStation - 00606959028470

DreamStation CPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation CPAP w/Humidifier, w/Heated Tube, LA
Not in Commercial Distribution

  • 00606959028470 ()
LAX200T15

  • Home CPAP unit

DreamStation - 00606959026667

DreamStation Auto BiPAP with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, CA
In Commercial Distribution

  • 00606959026667 ()
CAX700T12

  • Home BPAP unit

DreamStation - 00606959026636

DreamStation BiPAP Pro with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959026636 ()
CAX600T12

  • Home BPAP unit
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