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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 - 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 - 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 - 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 - 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

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

n/a - 00607411891786

Percent-O2-Lock® Mask (Adult) with foam cushions with 7’ (2.1 m) supply tube.
SALTER LABS
8150TLC-7
In Commercial Distribution

  • 10607411891783 ()
  • 00607411891786 ()

  • Adult
8150TLC-7

  • Non-rebreathing oxygen face mask

N/A - 00607411500619

Adult Oral/Nasal Pressure Monitoring Cannula with 2’ (0.6 m) tube with filter.
SALTER LABS
5005-2
In Commercial Distribution

  • 10607411500616 ()
  • 00607411500619 ()

  • Adult
5005-2

  • Respiratory apnoea monitoring system
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