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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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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

AF531 - 00606959012325

AF531 Mask with Standard Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 PT Headgear, Medium, USA
Not in Commercial Distribution

  • 30606959012326 ()
  • 00606959012325 ()
1094809

  • CPAP/BPAP face mask, single-use

DreamWear - 00606959026964

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

  • 00606959026964 ()
1125022

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959026940

DreamWear Gel Pillows Mask, Large, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, L , Sm Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026940 ()
1125020

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959026919

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

  • 00606959026919 ()
1125017

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959026896

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 - 00606959024533

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 - 00606959024519

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
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