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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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DreamWear Gel Pillows Mask, Small, with Medium Frame, with Headgear, Global ,
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Medium Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026896 ()
1125015

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

  • 30606959024596 ()
  • 00606959024595 ()
1121073

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 2, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4-Point Headgear, Medium
In Commercial Distribution

  • 30606959024534 ()
  • 00606959024533 ()
1121067

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, X-Large
In Commercial Distribution

  • 30606959024510 ()
  • 00606959024519 ()
1121495

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, XLarge, US
In Commercial Distribution

  • 30606959024435 ()
  • 00606959024434 ()
1121065

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Large
Respironics, Inc.
AF541 Mask EE, Leak 1, w/ 4 Point Headgear, Large
In Commercial Distribution

  • 30606959024381 ()
  • 00606959024380 ()
1121060

  • CPAP/BPAP face mask, single-use
Wisp Pediatric Mask Fit Pack with Headgear, with Entrainment Elbow, USA
Respironics, Inc.
Wisp Pediatric Fitpack with Headgear, EE, US
In Commercial Distribution

  • 00606959024236 ()
1104953

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask with Standard Elbow, with Headgear, Small, International
Respironics, Inc.
ComfortGel Blue Nasal Mask w/SE, w/Headgr, Small, INTL
In Commercial Distribution

  • 00606959020825 ()
1070070

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask with Standard Elbow, with Headgear, Large, International
Respironics, Inc.
ComfortGel Blue Nasal Mask w/SE, w/Headgr, Large, INTL
In Commercial Distribution

  • 00606959020818 ()
1070068

  • CPAP/BPAP nasal mask, reusable
REMstar SE with Heated Humidifier, Standard Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE w/HTD Humid, St Tube, with SD Slot, CA
In Commercial Distribution

  • 00606959020092 ()
CA221NTS

  • Home CPAP unit
  • Heated respiratory humidifier
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