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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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PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, MEDIUM
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959007551 ()
  • 00606959007550 ()
1048720

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, SMALL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, SMALL
In Commercial Distribution

  • 30606959007544 ()
  • 00606959007543 ()
1048721

  • CPAP/BPAP face mask, single-use
REMstar Auto A-Flex with Humidifier, with SD Card, China
Respironics, Inc.
REMstar Auto A-Flex with Humidifier, with SD Card, China
Not in Commercial Distribution

  • 00606959001046 ()
CN557HS

  • Home CPAP unit
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 AE with Humidifier with WiFi, Australia
Respironics, Inc.
DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, AU
In Commercial Distribution

  • 00606959045743 ()
AUX1131H15W

  • Portable electric ventilator
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 AVAPS30 AAM with Humidifier, with WiFi, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CA
In Commercial Distribution

  • 00606959045682 ()
CAX1130H12W

  • 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
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