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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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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

AF541 - 00606959024472

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

  • 30606959024473 ()
  • 00606959024472 ()
1121491

  • CPAP/BPAP face mask, single-use

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

AMARA GEL - 00606959025301

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

  • 00606959025301 ()
1090450

  • CPAP/BPAP face mask, reusable

AMARA GEL - 00606959025257

AMARA GEL MASK WITH STANDARD ELBOW, WITH RS FRAME AND HEADGEAR, LARGE, INTERNATIONAL
Respironics, Inc.
AMARA GEL MASK SE WITH RS FRAME AND HEADGEAR INTL, LARGE
In Commercial Distribution

  • 00606959025257 ()
1090436

  • CPAP/BPAP face mask, reusable

AMARA GEL - 00606959025240

AMARA GEL MASK WITH STANDARD ELBOW, WITH RS FRAME AND HEADGEAR, MEDIUM, INTERNATIONAL
Respironics, Inc.
AMARA GEL MASK SE WITH RS FRAME AND HEADGEAR INTL, MEDIUM
In Commercial Distribution

  • 00606959025240 ()
1090435

  • CPAP/BPAP face mask, reusable
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