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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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AF531 Mask with Standard Elbow with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask, SE with CapStrap, Small, Single Use
Not in Commercial Distribution

  • 00606959007277 ()
1061730

  • CPAP/BPAP face mask, single-use
Performatrak Mask with Standard Elbow, with Headgear, Dispossable, Medium, Korea
Respironics, Inc.
Performatrak SE Mask w/Headgear, Disp, MEDIUM, KR
Not in Commercial Distribution

  • 30606959027702 ()
  • 00606959027701 ()
1119725

  • CPAP/BPAP face mask, single-use
Performatrak Mask with Standard Elbow, with Headgear, Disposable, Large, Korea
Respironics, Inc.
Performatrak SE Mask w/Headgear, Disp, LARGE, KR
Not in Commercial Distribution

  • 30606959027689 ()
  • 00606959027688 ()
1119726

  • CPAP/BPAP face mask, single-use
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
AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Medium
Respironics, Inc.
AF541 Mask, EE, LEAK 2 WITH CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959024572 ()
  • 00606959024571 ()
1121071

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Small
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, SMALL
In Commercial Distribution

  • 30606959024565 ()
  • 00606959024564 ()
1121070

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

  • 30606959024503 ()
  • 00606959024502 ()
1121494

  • CPAP/BPAP face mask, single-use
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