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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 - 00606959004597

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 - 00606959041295

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 - 00606959041288

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 - 00606959041271

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 - 00606959040984

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 - 00606959040717

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 System One 60 Series - 00606959037762

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 - 00606959030916

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 - 00606959028968

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 - 00606959024465

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
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