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

  • 00606959054493 ()
1139336

  • CPAP/BPAP nasal mask, reusable
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 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
AF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, Medium
Respironics, Inc.
AF531 Mask w/SE, with 4 point Headgear, Medium, SU
Not in Commercial Distribution

  • 00606959007468 ()
1061722

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, Small
Respironics, Inc.
AF531 Mask w/SE, with 4 point Headgear, Small, Single Use
Not in Commercial Distribution

  • 00606959007451 ()
1061721

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

  • 30606959007377 ()
  • 00606959007376 ()
1119019

  • CPAP/BPAP face mask, single-use
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