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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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AAF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, China, Small
Respironics, Inc.
AF531 Mask w/SE, w/4 PT Headgear, SU, Small, CN
Not in Commercial Distribution

  • 30606959008688 ()
  • 00606959008687 ()
1119074

  • CPAP/BPAP face mask, single-use
A531 Mask with Entrainment Elbow, LEAK1, Nebulizing Elbow, with CapStrap, Single Use, Large
Respironics, Inc.
A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap, Large, SU
In Commercial Distribution

  • 30606959007322 ()
  • 00606959007321 ()
1119014

  • CPAP/BPAP face mask, single-use
A531 Mask with Entrainment Elbow, LEAK1, Nebulizing Elbow, with CapStrap, Single Use, Medium
Respironics, Inc.
A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SU
In Commercial Distribution

  • 30606959007315 ()
  • 00606959007314 ()
1119013

  • CPAP/BPAP face mask, single-use
A531 Mask with Entrainment Elbow, LEAK1, Nebulizing Elbow, with CapStrap, Single Use, Small
Respironics, Inc.
A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, Small, SU
In Commercial Distribution

  • 30606959007308 ()
  • 00606959007307 ()
1119012

  • CPAP/BPAP face mask, single-use
PerformaTrak Mask with Entrainment Elbow, with 4 Point Headgear, Single Use, China, Large
Respironics, Inc.
PerformaTrak EE Mask w/4 PT Headgear, SU, Large, CN
Not in Commercial Distribution

  • 00606959009448 ()
CN1012635

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

  • 00606959030879 ()
1116691

  • CPAP/BPAP nasal mask, reusable
DreamWear Under the Nose Nasal Mask, Large, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, L, S Frame w/Headgear, Global
In Commercial Distribution

  • 00606959030848 ()
1116687

  • CPAP/BPAP nasal mask, reusable
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 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
AF541 Under the Nose Mask with Standard Elbow, with Capstrap, Size C, Japan
Respironics, Inc.
AF541 Mask with SE, Under Nose, w/Capstrap, Size C, JP
Not in Commercial Distribution

  • 30606959041333 ()
  • 00606959041332 ()
1129498

  • CPAP/BPAP face mask, single-use
AF541 Under the Nose Mask with Standard Elbow, with Capstrap, Size B, Japan
Respironics, Inc.
AF541 Mask with SE, Under Nose, w/Capstrap, Size B, JP
Not in Commercial Distribution

  • 30606959041326 ()
  • 00606959041325 ()
1129387

  • CPAP/BPAP face mask, single-use
AF541 Under the Nose Mask with Standard Elbow, with Capstrap, Size A, Japan
Respironics, Inc.
AF541 Mask with SE, Under the Nose, Capstrap, Size A, JP
Not in Commercial Distribution

  • 30606959041319 ()
  • 00606959041318 ()
1129386

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Capstrap, Size Extra Large, Japan
Respironics, Inc.
AF541 Mask EE, Leak 1, Capstrap, Size XL, JP
Not in Commercial Distribution

  • 30606959041302 ()
  • 00606959041301 ()
1129503

  • CPAP/BPAP face mask, single-use
DreamStation AVAPS 30 AE, with Humidifier, with Heated Tubing, No Blue Tooth, International
Respironics, Inc.
DreamStation AVAPS 30 AE AAM w/Hum w/HTube, no BT, INTL
In Commercial Distribution

  • 00606959041011 ()
INX1131T19

  • Portable electric ventilator
REMstar SE Auto with Heated Humidifier and Standard Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto w/Htd Humid and St Tube, w/SD Slot, CA
In Commercial Distribution

  • 00606959036772 ()
CA521NTS

  • Home CPAP unit
  • Heated respiratory humidifier
DreamWear Under the Nose Nasal Mask, Large, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, L, L Frame w/Headgear, Global
In Commercial Distribution

  • 00606959030886 ()
1116692

  • CPAP/BPAP nasal mask, reusable
DreamWear Under the Nose Nasal Mask, Small, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, S, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030862 ()
1116690

  • CPAP/BPAP nasal mask, reusable
DreamWear Under the Nose Nasal Mask, Large, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, L, M Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030718 ()
1116682

  • CPAP/BPAP nasal mask, reusable
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 MASK WITH STANDARD ELBOW, WITH RS FRAME AND HEADGEAR, LARGE, JAPAN
Respironics, Inc.
AMARA GEL MASK w/SE, with RS FRAME, Headgear, Large, JP
Not in Commercial Distribution

  • 00606959025332 ()
1090456

  • CPAP/BPAP face mask, reusable
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 MASK WITH STANDARD ELBOW WITH RS FRAME AND HEADGEAR JPN, SMALL
Respironics, Inc.
AMARA GEL MASK w/SE, with RS FRAME, Headgear, Small, JP
Not in Commercial Distribution

  • 00606959025318 ()
1090451

  • CPAP/BPAP face mask, reusable
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 MASK WITH STANDARD ELBOW, WITH RS FRAME AND HEADGEAR, LARGE, INTERNATIONAL
Respironics, Inc.
AMARA GEL MASK SE WITH RS FRAME AND HEADGEAR INTL, LARGE
In Commercial Distribution

  • 00606959025257 ()
1090436

  • CPAP/BPAP face mask, reusable
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 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
AF541 Mask with Entrainment Elbow, Leak 2, with 4 Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH 4-POINT HEADGEAR, X-LARGE
In Commercial Distribution

  • 30606959024558 ()
  • 00606959024557 ()
1121069

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with 4 Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with 4 Point Headgear, X-Large
In Commercial Distribution

  • 30606959024473 ()
  • 00606959024472 ()
1121491

  • CPAP/BPAP face mask, single-use
AMARA MASK with STANDARD ELBOW, with RS FRAME, and RS HEADGEAR, INTERNATIONAL, PETITE
Respironics, Inc.
Amara Mask w/SE, Petite, w/RS Frame w/RS Headgr,INTL
In Commercial Distribution

  • 00606959015005 ()
1090230

  • CPAP/BPAP face mask, reusable
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
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