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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 - 00606959012349

AF531 Mask with Entrainment Elbow (Nebulizing Elbow), with Four Point Headgear, Small, USA
Respironics, Inc.
AF531 Mask EE (NE) with 4 point Headgear, Small, USA
In Commercial Distribution

  • 30606959012340 ()
  • 00606959012349 ()
1094811

  • CPAP/BPAP face mask, single-use

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 - 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

DreamWear - 00606959030787

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

  • 00606959030787 ()
1116685

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959030718

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

  • 00606959030718 ()
1116682

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959030688

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

  • 00606959030688 ()
1116681

  • CPAP/BPAP nasal mask, reusable

AMARA GEL - 00606959025332

AMARA GEL MASK WITH STANDARD ELBOW, WITH RS FRAME AND HEADGEAR, LARGE, JAPAN
Respironics, Inc.
AMARA GEL MASK w/SE, with RS FRAME, Headgear, Large, JP
Not in Commercial Distribution

  • 00606959025332 ()
1090456

  • CPAP/BPAP face mask, reusable

AMARA GEL - 00606959025325

AMARA GEL MASK WITH STANDARD ELBOW WITH RS FRAME AND HEADGEAR, MEDIUM, JAPAN
Respironics, Inc.
AMARA GEL MASK w/SE, with RS FRAME, Headgear, Medium, JP
Not in Commercial Distribution

  • 00606959025325 ()
1090455

  • CPAP/BPAP face mask, reusable

AMARA GEL - 00606959025318

AMARA GEL MASK WITH STANDARD ELBOW WITH RS FRAME AND HEADGEAR JPN, SMALL
Respironics, Inc.
AMARA GEL MASK w/SE, with RS FRAME, Headgear, Small, JP
Not in Commercial Distribution

  • 00606959025318 ()
1090451

  • CPAP/BPAP face mask, reusable
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