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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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AF531 Mask with Standard Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 PT Headgear, Medium, USA
Not in Commercial Distribution

  • 30606959012326 ()
  • 00606959012325 ()
1094809

  • CPAP/BPAP face mask, single-use
DreamWear Gel Pillows Mask, Medium, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026964 ()
1125022

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Large, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, L , Sm Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026940 ()
1125020

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Large, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, L, Med Frame w/ Headgr, Global
In Commercial Distribution

  • 00606959026919 ()
1125017

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Small, with Medium Frame, with Headgear, Global ,
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Medium Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026896 ()
1125015

  • CPAP/BPAP nasal mask, reusable
AF541 Mask with Entrainment Elbow, Leak 2, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4-Point Headgear, Medium
In Commercial Distribution

  • 30606959024534 ()
  • 00606959024533 ()
1121067

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, X-Large
In Commercial Distribution

  • 30606959024510 ()
  • 00606959024519 ()
1121495

  • CPAP/BPAP face mask, single-use
Wisp Pediatric Mask Fit Pack with Headgear, with Entrainment Elbow, USA
Respironics, Inc.
Wisp Pediatric Fitpack with Headgear, EE, US
In Commercial Distribution

  • 00606959024236 ()
1104953

  • CPAP/BPAP nasal mask, reusable
REMstar SE with Heated Humidifier, Standard Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE w/HTD Humid, St Tube, with SD Slot, CA
In Commercial Distribution

  • 00606959020092 ()
CA221NTS

  • Home CPAP unit
  • Heated respiratory humidifier
AF531, with Entrainment Elbow (Nebulizing Elbow), with CapStrap HeadGear, Medium, USA
Respironics, Inc.
AF531 Mask EE (NE) with CapStrap, Medium, USA
Not in Commercial Distribution

  • 30606959012388 ()
  • 00606959012387 ()
1094815

  • CPAP/BPAP face mask, single-use
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