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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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Wisp Mask, with Standard Elbow, Clear Frame, with Headgear, China
Respironics, Inc.
Wisp Mask, w/SE, Clear Frame, with Headgear, China
Not in Commercial Distribution

  • 00606959040106 ()
1109312

  • CPAP/BPAP nasal mask, reusable
REMstar SE Auto, with Heated Humidifier, with SD Slot, Domestic
Respironics, Inc.
REMstar SE Auto, w/Heated Tube Humid and SD Slot, US
In Commercial Distribution

  • 00606959037090 ()
DS520TS

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar SE Auto with Heated Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto with Heated Humidifier, w/SD Slot, CA
In Commercial Distribution

  • 00606959036765 ()
CA521TS

  • Home CPAP unit
  • Heated respiratory humidifier
AF531 Mask with Entrainment Elbow, Leak1, with CapStrap, China, Large
Respironics, Inc.
AF531 Mask EE, Leak1 with CapStrap, Large, China
In Commercial Distribution

  • 30606959027818 ()
  • 00606959027817 ()
1126275

  • CPAP/BPAP face mask, single-use
DreamWear Gel Pillows Mask, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026780 ()
1124984

  • CPAP/BPAP nasal mask, reusable
Wisp Pediatric Mask Fitpack with Headgear, with Entrainment Elbow, International
Respironics, Inc.
Wisp Pediatric Fitpack with Headgear, EE, INTL
In Commercial Distribution

  • 00606959026735 ()
1104961

  • CPAP/BPAP nasal mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Large, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Large, JP
In Commercial Distribution

  • 00606959024793 ()
1090654

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Medium, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Medium, JP
In Commercial Distribution

  • 00606959024786 ()
1090653

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Small, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Small, JP
In Commercial Distribution

  • 00606959024779 ()
1090652

  • CPAP/BPAP face mask, reusable
AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, LARGE
In Commercial Distribution

  • 30606959024589 ()
  • 00606959024588 ()
1121072

  • CPAP/BPAP face mask, single-use
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