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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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DreamWisp - 00606959057296

DreamWisp Nasal Mask, Small Cushion with Medium Connector with Headgear, Central Eastern Europe
Respironics, Inc.
DreamWisp Nasal Mask, Small, Med Connector w/Headgear, CEE
In Commercial Distribution

  • 00606959057296 ()
1137943CE

  • CPAP/BPAP nasal mask, reusable

DreamWear Full - 00606959054448

DreamWear Full Mask, Small, with Medium Frame with Headgear, United States of America
Respironics, Inc.
DreamWear Full Mask, S, M Frame with Headgear, USA
In Commercial Distribution

  • 00606959054448 ()
1140235

  • CPAP/BPAP nasal 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 - 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

AMARA GEL - 00606959025226

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

  • 00606959025226 ()
1090430

  • CPAP/BPAP face mask, reusable

AF541 - 00606959024557

AF541 Mask with Entrainment Elbow, Leak 2, with 4 Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH 4-POINT HEADGEAR, X-LARGE
In Commercial Distribution

  • 30606959024558 ()
  • 00606959024557 ()
1121069

  • CPAP/BPAP face mask, single-use

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 - 00606959015005

AMARA MASK with STANDARD ELBOW, with RS FRAME, and RS HEADGEAR, INTERNATIONAL, PETITE
Respironics, Inc.
Amara Mask w/SE, Petite, w/RS Frame w/RS Headgr,INTL
In Commercial Distribution

  • 00606959015005 ()
1090230

  • CPAP/BPAP face mask, reusable
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