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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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DreamWisp Nasal, Medium with Medium Connector with Headgear, International
Respironics, Inc.
DreamWisp Mask, Medium, Med Connector, W/Headgear, INTL
In Commercial Distribution

  • 00606959051126 ()
1137944

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal, Petite with Medium Connector with Headgear, International
Respironics, Inc.
DreamWisp Mask, Petite, Med Connector, W/Headgear, INTL
In Commercial Distribution

  • 00606959051102 ()
1137942

  • CPAP/BPAP nasal mask, reusable
DreamWear Full Mask with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Full Mask w/Medium Frame w/Headgear, Global
In Commercial Distribution

  • 00606959045897 ()
1133400

  • CPAP/BPAP nasal mask, reusable
DreamStation BiPAP AVAPS30 with Humidifier, with Cell Modem, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CA
In Commercial Distribution

  • 00606959045712 ()
CAX1130H12C

  • Portable electric ventilator
DreamStation BiPAP AVAPS 30 with Humidifier, with WiFi, USA
Respironics, Inc.
DreamStation AVAPS30 w/Humidifier w/WiFi, US
In Commercial Distribution

  • 00606959045620 ()
DSX1130H11W

  • Portable electric ventilator
DreamStation CPAP Pro with C Flex with Humidifier, GB
Respironics, Inc.
DreamStation CPAP Pro with C Flex with Humidifier, GB
In Commercial Distribution

  • 00606959043824 ()
GBX401H15

  • Home CPAP unit
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
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 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
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