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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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DreamWisp - 00606959054455

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

  • 00606959054455 ()
1139332

  • CPAP/BPAP nasal mask, reusable

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

DreamWisp - 00606959051140

DreamWisp Nasal Mask, Extra Large with Medium Connector With Headgear, International
Respironics, Inc.
DreamWisp Mask, Xlarge, MedConnector, wHeadgear, INTL
In Commercial Distribution

  • 00606959051140 ()
1137946

  • CPAP/BPAP nasal mask, reusable

DreamWear Full - 00606959046146

DreamWear Full Mask, Medium Wide, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Full Mask Medium Wide, w/Large Frame w/Headgear, Global
In Commercial Distribution

  • 00606959046146 ()
1133393

  • CPAP/BPAP nasal mask, reusable

WISP - 00606959040090

Wisp Nasal Mask with Standard Elbow, with Headgear, Clear Frame, Japan
Respironics, Inc.
Wisp Nasal Mask w/SE, with Headgear, Clear Frame, JP
Not in Commercial Distribution

  • 00606959040090 ()
1094070

  • CPAP/BPAP nasal mask, reusable

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 - 00606959026940

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 - 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
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