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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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PERFORMATRAK - 00606959027701

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 - 00606959027688

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

DreamWear - 00606959026988

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

  • 00606959026988 ()
1125024

  • CPAP/BPAP nasal mask, reusable

Amara View - 00606959024793

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 - 00606959024779

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 - 00606959024571

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 - 00606959024489

AF541 Mask with Entrainment Elbow, Leak 1, with Capstrap, Small
Respironics, Inc.
AF541 Mask, EE, Leak 1, with Capstrap, Small
In Commercial Distribution

  • 30606959024480 ()
  • 00606959024489 ()
1121492

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024427

AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Large
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Large, US
In Commercial Distribution

  • 30606959024428 ()
  • 00606959024427 ()
1121064

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024410

AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Medium, US
In Commercial Distribution

  • 30606959024411 ()
  • 00606959024410 ()
1121063

  • CPAP/BPAP face mask, single-use

ComfortGel - 00606959022249

ComfortGel Blue Mask with Standard Elbow, with Headgear, Medium, International
Respironics, Inc.
ComfortGel Blue Mask w/SE, w/Headgear, Medium, INTL
In Commercial Distribution

  • 00606959022249 ()
1070069

  • CPAP/BPAP nasal mask, reusable
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