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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, Nebulizing Elbow, with CapStrap, Single Use, Large
Respironics, Inc.
00606959007352
Not in Commercial Distribution

  • 30606959007353 ()
  • 00606959007352 ()
1119017

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, Nebulizing Elbow, with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Small, SU
Not in Commercial Distribution

  • 30606959007339 ()
  • 00606959007338 ()
1119015

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Large, Single Use
Respironics, Inc.
AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use
In Commercial Distribution

  • 30606959004604 ()
  • 00606959004603 ()
1119011

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, Leak 2, with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU
In Commercial Distribution

  • 30606959007360 ()
  • 00606959007369 ()
1119018

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, Nebulizing Elbow, with CapStrap, Single Use, Medium
Respironics, Inc.
AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Medium, SU
Not in Commercial Distribution

  • 30606959007346 ()
  • 00606959007345 ()
1119016

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Medium, Single Use
Respironics, Inc.
AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use
In Commercial Distribution

  • 30606959004598 ()
  • 00606959004597 ()
1119010

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

  • 30606959041296 ()
  • 00606959041295 ()
1129502

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

  • 30606959041289 ()
  • 00606959041288 ()
1129501

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

  • 30606959041272 ()
  • 00606959041271 ()
1129500

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

  • 00606959040984 ()
INX1130T19

  • Portable electric ventilator
DreamStation BiPAP S/T25 with Humidifier, with Heated Tube, no BlueTooth, International
Respironics, Inc.
DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, INTL
In Commercial Distribution

  • 00606959040717 ()
INX1025T19

  • Portable electric ventilator
REMstar Auto with Heated Humidifier, with BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto w/HTD Humid, BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959037762 ()
CA561TBT

  • Home CPAP unit
DreamWear Under the Nose Nasal Mask, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, M Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030916 ()
1116700

  • CPAP/BPAP nasal mask, reusable
AF531 Mask with Entrainment Elbow, Leak 1, with CapStrap, Single, Medium, China
Respironics, Inc.
AF531 Mask EE, Leak1 with CapStrap, Medium, China
Not in Commercial Distribution

  • 00606959028968 ()
CN1061728

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

  • 30606959024466 ()
  • 00606959024465 ()
1121490

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

  • 30606959024459 ()
  • 00606959024458 ()
1121489

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

  • 30606959024442 ()
  • 00606959024441 ()
1121488

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

  • 30606959024398 ()
  • 00606959024397 ()
1121061

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

  • 30606959024367 ()
  • 00606959024366 ()
1121058

  • CPAP/BPAP face mask, single-use
Amara Mask with Standard Elbow with RS Frame and Headgear, International, Small
Respironics, Inc.
Amara Mask with SE, Small, with RS Frame and Headgear, INTL
In Commercial Distribution

  • 00606959015012 ()
1090231

  • CPAP/BPAP face mask, reusable
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