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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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Dorma 400 with Humidifier, Germany
Respironics, Inc.
Dorma 400 with Humidifier, DE
In Commercial Distribution

  • 00606959036826 ()
DEV402H

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 200 with Humidifier, France
Respironics, Inc.
Dorma 200 with Humidifier, FR
In Commercial Distribution

  • 00606959036802 ()
FRV201H

  • Home CPAP unit
  • Heated respiratory humidifier
AF811 Mask with Headgear, Medium
Respironics, Inc.
AF811 Mask with Headgear, Medium, Single Use
In Commercial Distribution

  • 30606959034359 ()
  • 00606959034358 ()
1120252

  • CPAP/BPAP face mask, single-use
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
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