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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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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

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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