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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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Salter AIRE Elite, NebuTech - 00607411001536

Salter Air Elite® with NebuTech® HDN®, with Nebulizer
SALTER LABS
8352-8660-7-1
In Commercial Distribution

  • 00607411001536 ()
8352-8660-7-1

  • Benchtop nebulizer, non-heated

DreamWisp - 00606959057289

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

  • 00606959057289 ()
1137942CE

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959054462

DreamWisp Nasal Mask, Small with Small Medium Connector with Headgear, Korea
Respironics, Inc.
DREAMWISP Mask, Small, Sm/Med Connector W/Headgear, KR
Not in Commercial Distribution

  • 00606959054462 ()
1139333

  • CPAP/BPAP nasal mask, reusable

AF531 - 00606959012233

AF531 Mask with Entrainment Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask EE with 4 point Headgear, Medium, USA
In Commercial Distribution

  • 30606959012234 ()
  • 00606959012233 ()
1094800

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959034129

DreamStation Auto CPAP with Humidifier, with Heated Tube, and WiFi, Domestic
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/H Tube w/WiFi, US
In Commercial Distribution

  • 00606959034129 ()
DSX500T11W

  • Home CPAP unit

DreamWear - 00606959026971

DreamWear Gel Pillows Mask, Large, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, Large, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026971 ()
1125023

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959026957

DreamWear Gel Pillows Mask, Small, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Large Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026957 ()
1125021

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959026926

DreamWear Gel Pillows Mask, Small, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Small Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026926 ()
1125018

  • CPAP/BPAP nasal mask, reusable

DreamWear - 00606959026902

DreamWear Gel Pillows Mask, Medium, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, Med Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026902 ()
1125016

  • CPAP/BPAP nasal mask, reusable

AF541 - 00606959024595

AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, X-LARGE
In Commercial Distribution

  • 30606959024596 ()
  • 00606959024595 ()
1121073

  • CPAP/BPAP face mask, single-use
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