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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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AF811 Mask with Headgear, Large
Respironics, Inc.
AF811 Mask with Headgear, Large, Single Use
In Commercial Distribution

  • 30606959034342 ()
  • 00606959034341 ()
1120251

  • CPAP/BPAP face mask, single-use
DreamStation CPAP with WiFi, USA
Respironics, Inc.
DreamStation CPAP w/WiFi, US
In Commercial Distribution

  • 00606959034044 ()
DSX200S11W

  • Home CPAP unit
REMstar Pro, with BlueTooth, Canada
Respironics, Inc.
REMstar Pro w/BlueTooth, CA
In Commercial Distribution

  • 00606959030169 ()
461CABT

  • Home CPAP unit
DreamStation CPAP with Humidifier, EU
Respironics, Inc.
DreamStation CPAP with Humidifier, EU
In Commercial Distribution

  • 00606959027404 ()
EUX200H15

  • Home CPAP unit
DreamStation CPAP with Humidifier, ZA
Respironics, Inc.
DreamStation CPAP with Humidifier, ZA
In Commercial Distribution

  • 00606959027398 ()
ZAX200H15

  • Home CPAP unit
DreamStation CPAP with Humidifier, Italy
Respironics, Inc.
DreamStation CPAP with Humidifier, IT
Not in Commercial Distribution

  • 00606959027244 ()
ITX200H15

  • Home CPAP unit
DreamStation CPAP with Humidifier, ND
Respironics, Inc.
DreamStation CPAP with Humidifier, ND
Not in Commercial Distribution

  • 00606959027176 ()
NDX200H15

  • Home CPAP unit
DreamStation CPAP with Humidifier, Canada
Respironics, Inc.
DreamStation CPAP with Humidifier, CA
In Commercial Distribution

  • 00606959026537 ()
CAX200H12

  • Home CPAP unit
Garbin Ventilator, with Bluetooth, Germany
Respironics, Inc.
Garbin Ventilator, Bluetooth, DE
In Commercial Distribution

  • 00606959026490 ()
1040001B

  • Portable electric ventilator
DreamStation CPAP with Humidifier, Spain
Respironics, Inc.
DreamStation CPAP with Humidifier, ES
Not in Commercial Distribution

  • 00606959024304 ()
ESX200H15

  • Home CPAP unit
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