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 MASK WITH RS FRAME AND HEADGEAR, MEDIUM, JAPAN
Respironics, Inc.
AMARA GEL MASK with RS FRAME and Headgear, Medium, JP
Not in Commercial Distribution

  • 00606959025288 ()
1090445

  • CPAP/BPAP face mask, reusable
AMARA GEL MASK WITH RS FRAME AND HEADGEAR, SMALL, JAPAN
Respironics, Inc.
AMARA GEL MASK with RS FRAME and Headgear, Small, JP
Not in Commercial Distribution

  • 00606959025271 ()
1090441

  • CPAP/BPAP face mask, reusable
AMARA GEL MASK WITH RS FRAME AND HEADGEAR, PETITE, JAPAN
Respironics, Inc.
AMARA GEL MASK with RS FRAME and Headgear, Petite, JP
Not in Commercial Distribution

  • 00606959025264 ()
1090440

  • CPAP/BPAP face mask, reusable
AMARA MASK SE WITH RS FRAME AND HEADGEAR, LARGE, JAPAN
Respironics, Inc.
AMARA MASK w/SE w/RS FRAME and Headgr, Large, JN
Not in Commercial Distribution

  • 00606959025134 ()
1090256

  • CPAP/BPAP face mask, reusable
AMARA MASK SE WITH RS FRAME AND HEADGEAR, MEDIUM, JAPAN
Respironics, Inc.
AMARA MASK SE with RS FRAME and Headgear, Medium, Japan
Not in Commercial Distribution

  • 00606959025127 ()
1090255

  • CPAP/BPAP face mask, reusable
AMARA MASK WITH RS FRAME AND RS HEADGEAR SMALL, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME AND RS Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959025073 ()
1090241

  • CPAP/BPAP face mask, reusable
AMARA MASK WITH RS FRAME AND RS HEADGEAR PETITE, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME and RS Headgear, Petite, Japan
Not in Commercial Distribution

  • 00606959025066 ()
1090240

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Large, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Large, JP
In Commercial Distribution

  • 00606959024793 ()
1090654

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Medium, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Medium, JP
In Commercial Distribution

  • 00606959024786 ()
1090653

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Small, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Small, JP
In Commercial Distribution

  • 00606959024779 ()
1090652

  • CPAP/BPAP face mask, reusable
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