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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 - 00606959008700

AF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, China, Large
Respironics, Inc.
AF531 Mask w/SE, w/4 PT Headgear, SU, Large, CN
Not in Commercial Distribution

  • 30606959008701 ()
  • 00606959008700 ()
1119076

  • CPAP/BPAP face mask, single-use

AF531 - 00606959008687

AAF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, China, Small
Respironics, Inc.
AF531 Mask w/SE, w/4 PT Headgear, SU, Small, CN
Not in Commercial Distribution

  • 30606959008688 ()
  • 00606959008687 ()
1119074

  • CPAP/BPAP face mask, single-use

AF531 - 00606959007321

A531 Mask with Entrainment Elbow, LEAK1, Nebulizing Elbow, with CapStrap, Single Use, Large
Respironics, Inc.
A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap, Large, SU
In Commercial Distribution

  • 30606959007322 ()
  • 00606959007321 ()
1119014

  • CPAP/BPAP face mask, single-use

AF531 - 00606959007314

A531 Mask with Entrainment Elbow, LEAK1, Nebulizing Elbow, with CapStrap, Single Use, Medium
Respironics, Inc.
A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SU
In Commercial Distribution

  • 30606959007315 ()
  • 00606959007314 ()
1119013

  • CPAP/BPAP face mask, single-use

AF531 - 00606959007307

A531 Mask with Entrainment Elbow, LEAK1, Nebulizing Elbow, with CapStrap, Single Use, Small
Respironics, Inc.
A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, Small, SU
In Commercial Distribution

  • 30606959007308 ()
  • 00606959007307 ()
1119012

  • CPAP/BPAP face mask, single-use

DreamWear - 00606959030886

DreamWear Under the Nose Nasal Mask, Large, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, L, L Frame w/Headgear, Global
In Commercial Distribution

  • 00606959030886 ()
1116692

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959030879

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

  • 00606959030879 ()
1116691

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959030862

DreamWear Under the Nose Nasal Mask, Small, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, S, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030862 ()
1116690

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959030848

DreamWear Under the Nose Nasal Mask, Large, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, L, S Frame w/Headgear, Global
In Commercial Distribution

  • 00606959030848 ()
1116687

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959030824

DreamWear Under the Nose Nasal Mask, Medium, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, M, S Frame with Headgear, Global
In Commercial Distribution

  • 00606959030824 ()
1116686

  • CPAP/BPAP nasal mask, reusable
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