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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 - 00606959026926

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

  • 00606959026926 ()
1125018

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959026902

DreamWear Gel Pillows Mask, Medium, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, Med Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026902 ()
1125016

  • CPAP/BPAP nasal mask, reusable

AF541 - 00606959024595

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 - 00606959024526

AF541 Mask with Entrainment Elbow, Leak 2, with Four-Point Headgear, Small
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4 Point Headgear, Small
In Commercial Distribution

  • 30606959024527 ()
  • 00606959024526 ()
1121066

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024434

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 - 00606959024380

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

AF541 - 00606959024373

AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ 4 Point Headgear,Medium
In Commercial Distribution

  • 30606959024374 ()
  • 00606959024373 ()
1121059

  • CPAP/BPAP face mask, single-use

ComfortGel Blue - 00606959020825

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 - 00606959020818

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

AF531 - 00606959012394

AF531 Mask with Entrainment Elbow (Nebulizing Elbow) with CapStrap, USA, Large
Respironics, Inc.
AF531 Mask EE (Nebulizing Elbow) with CapStrap, Large, USA
Not in Commercial Distribution

  • 30606959012395 ()
  • 00606959012394 ()
1094816

  • CPAP/BPAP face mask, single-use
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