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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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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
DreamStation Auto CPAP with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022577 ()
AHX500T11

  • Home CPAP unit
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
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
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