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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 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 Full Mask, Medium Wide, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Full Mask Medium Wide, w/Small Frame w/Headgear, Global
In Commercial Distribution

  • 00606959046108 ()
1133388

  • CPAP/BPAP nasal mask, reusable
DreamWear Full Mask, Medium Wide, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Full Mask Medium Wide, w/Medium Frame w/Headgear, Global
In Commercial Distribution

  • 00606959046061 ()
1133383

  • CPAP/BPAP nasal mask, reusable
AF531 Mask with Entrainment Elbow, with 4 Point Headgear, Large, USA
Respironics, Inc.
AF531 Mask EE with 4 point Headgear, Large, USA
In Commercial Distribution

  • 30606959012241 ()
  • 00606959012240 ()
1094801

  • CPAP/BPAP face mask, single-use
PerformaTrak Full Mask with Standard Elbow, with CapStrap, Single Use, MEDIUM
Respironics, Inc.
PerformaTrak Full Mask, Medium, w/SE and CapStrap, SU
In Commercial Distribution

  • 00606959011618 ()
1063897

  • CPAP/BPAP face mask, single-use
PerformaTrak Full Mask with Standard Elbow, with CapStrap, Single Use, SMALL
Respironics, Inc.
PerformaTrak Full Mask, Small, w/SE w/CapStrap, SU
In Commercial Distribution

  • 00606959011601 ()
1063836

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask EE with 4 point Headgear, Medium, USA
In Commercial Distribution

  • 30606959012234 ()
  • 00606959012233 ()
1094800

  • CPAP/BPAP face mask, single-use
Salter Air Elite® with NebuTech® HDN®, with Nebulizer.
SALTER LABS
8352-8984-7-1
In Commercial Distribution

  • 00607411102110 ()
8352-8984-7-1

  • Benchtop nebulizer, non-heated
DreamWisp Nasal, Extra Large with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, XL, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057272 ()
1137946AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Medium with Small Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, Med, Sm/Med CONNECTOR, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054479 ()
1139334

  • CPAP/BPAP nasal mask, reusable
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