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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 - 00606959004603

AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Large, Single Use
Respironics, Inc.
AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use
In Commercial Distribution

  • 30606959004604 ()
  • 00606959004603 ()
1119011

  • CPAP/BPAP face mask, single-use

AF531 - 00606959004597

AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Medium, Single Use
Respironics, Inc.
AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use
In Commercial Distribution

  • 30606959004598 ()
  • 00606959004597 ()
1119010

  • CPAP/BPAP face mask, single-use

DreamWear - 00606959030916

DreamWear Under the Nose Nasal Mask, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, M Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030916 ()
1116700

  • CPAP/BPAP nasal mask, reusable

AF541 - 00606959024540

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

  • 30606959024541 ()
  • 00606959024540 ()
1121068

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024465

AF541 Mask with Entrainment Elbow, Leak 1, with 4 Point Headgear, Large
Respironics, Inc.
AF541 Mask EE Leak 1, with 4 Point Headgear, Large
In Commercial Distribution

  • 30606959024466 ()
  • 00606959024465 ()
1121490

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024458

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

  • 30606959024459 ()
  • 00606959024458 ()
1121489

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024441

AF541 Mask with Entrainment Elbow, Leak 1, with 4 Point Headgear, Small
Respironics, Inc.
AF541 Mask EE, Leak 1, with 4 Point Headgear, Small
In Commercial Distribution

  • 30606959024442 ()
  • 00606959024441 ()
1121488

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024397

AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with 4 Point Headgear, XLarge
In Commercial Distribution

  • 30606959024398 ()
  • 00606959024397 ()
1121061

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024366

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

  • 30606959024367 ()
  • 00606959024366 ()
1121058

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959022621

DreamStation Auto BiPAP with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022621 ()
AHX700T11

  • Home BPAP unit
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