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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 Under the Nose Mask with Standard Elbow, with Capstrap, SIZE A
Respironics, Inc.
AF541 Mask, SE, Under Nose, w/Capstrap, SIZE A
In Commercial Distribution

  • 30606959046680 ()
  • 00606959046689 ()
1133717

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

  • 00606959022621 ()
AHX700T11

  • Home BPAP unit
DreamStation BiPAP Pro with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022607 ()
AHX600T11

  • Home BPAP unit
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