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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 - 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 - 00606959026919

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 - 00606959026896

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 - 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

AF541 - 00606959024533

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 - 00606959024526

AF541 Mask with Entrainment Elbow, Leak 2, with Four-Point Headgear, Small
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4 Point Headgear, Small
In Commercial Distribution

  • 30606959024527 ()
  • 00606959024526 ()
1121066

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024519

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

AF541 - 00606959024434

AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, XLarge, US
In Commercial Distribution

  • 30606959024435 ()
  • 00606959024434 ()
1121065

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024380

AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Large
Respironics, Inc.
AF541 Mask EE, Leak 1, w/ 4 Point Headgear, Large
In Commercial Distribution

  • 30606959024381 ()
  • 00606959024380 ()
1121060

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024373

AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ 4 Point Headgear,Medium
In Commercial Distribution

  • 30606959024374 ()
  • 00606959024373 ()
1121059

  • CPAP/BPAP face mask, single-use

Wisp Pediatric - 00606959024236

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

AF531 - 00606959012394

AF531 Mask with Entrainment Elbow (Nebulizing Elbow) with CapStrap, USA, Large
Respironics, Inc.
AF531 Mask EE (Nebulizing Elbow) with CapStrap, Large, USA
Not in Commercial Distribution

  • 30606959012395 ()
  • 00606959012394 ()
1094816

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012325

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

MSI Precision Specialty Instruments - 00194613094621

Silver Osteotome Left With Overall Length 7" (178mm) With Single Guard
Med Saver, Inc.
E8104
In Commercial Distribution

  • 00194613094621 ()


  • Orthopaedic osteotome

DreamWear Full - 00606959046108

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

  • 00606959046108 ()
1133388

  • CPAP/BPAP nasal mask, reusable

DreamWear Full - 00606959046061

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

  • 00606959046061 ()
1133383

  • CPAP/BPAP nasal mask, reusable

AF531 - 00606959012240

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

  • 30606959012241 ()
  • 00606959012240 ()
1094801

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959011618

PerformaTrak Full Mask with Standard Elbow, with CapStrap, Single Use, MEDIUM
Respironics, Inc.
PerformaTrak Full Mask, Medium, w/SE and CapStrap, SU
In Commercial Distribution

  • 00606959011618 ()
1063897

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959011601

PerformaTrak Full Mask with Standard Elbow, with CapStrap, Single Use, SMALL
Respironics, Inc.
PerformaTrak Full Mask, Small, w/SE w/CapStrap, SU
In Commercial Distribution

  • 00606959011601 ()
1063836

  • CPAP/BPAP face mask, single-use

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

Salter AIRE Elite, NebuTech - 00607411102110

Salter Air Elite® with NebuTech® HDN®, with Nebulizer.
SALTER LABS
8352-8984-7-1
In Commercial Distribution

  • 00607411102110 ()
8352-8984-7-1

  • Benchtop nebulizer, non-heated

DreamWisp - 00606959057272

DreamWisp Nasal, Extra Large with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, XL, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057272 ()
1137946AP

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959054479

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

  • 00606959054479 ()
1139334

  • CPAP/BPAP nasal mask, reusable

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

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

ComfortGel Blue - 00606959020825

ComfortGel Blue Nasal Mask with Standard Elbow, with Headgear, Small, International
Respironics, Inc.
ComfortGel Blue Nasal Mask w/SE, w/Headgr, Small, INTL
In Commercial Distribution

  • 00606959020825 ()
1070070

  • CPAP/BPAP nasal mask, reusable

ComfortGel Blue - 00606959020818

ComfortGel Blue Nasal Mask with Standard Elbow, with Headgear, Large, International
Respironics, Inc.
ComfortGel Blue Nasal Mask w/SE, w/Headgr, Large, INTL
In Commercial Distribution

  • 00606959020818 ()
1070068

  • CPAP/BPAP nasal mask, reusable

REMstar SE - 00606959020092

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 - 00606959012387

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

AF531 - 00606959012370

AF531, with Entrainment Elbow (Nebulizing Elbow), with CapStrap HeadGear, Small, USA
Respironics, Inc.
AF531 Mask EE (NE) with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012371 ()
  • 00606959012370 ()
1094814

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012332

AF531 Mask with Standard Elbow, with 4 Point Headgear, Large, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 Point Headgear, Large, USA
In Commercial Distribution

  • 30606959012333 ()
  • 00606959012332 ()
1094810

  • CPAP/BPAP face mask, single-use
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