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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PN841 Mask, Child Med, with Standard Elbow, Single Use, japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, SE, Single Use
Not in Commercial Distribution

  • 00606959041585 ()
1130571

  • CPAP/BPAP nasal mask, single-use
PN841 Mask, Child Small, with Standard Elbow, Single Use, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Small, SE, Single Use
Not in Commercial Distribution

  • 00606959041578 ()
1130570

  • CPAP/BPAP nasal mask, single-use
AF541 Mask with Standard Elbow with Capstrap, Size Large, Japan
Respironics, Inc.
AF541 Mask with SE, with Capstrap, Large, JP
Not in Commercial Distribution

  • 30606959041371 ()
  • 00606959041370 ()
1129506

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

  • 30606959041364 ()
  • 00606959041363 ()
1129505

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

  • 30606959041357 ()
  • 00606959041356 ()
1129504

  • CPAP/BPAP face mask, single-use
DreamWear Under the Nose Nasal, Medium Frame with Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, Med Frame w/Headgear, JP
Not in Commercial Distribution

  • 00606959040328 ()
1116730

  • CPAP/BPAP nasal mask, reusable
DreamWear Under Nose Mask, Wide, Large Frame with Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, Wide, L Frame w/Headgear, JP
Not in Commercial Distribution

  • 00606959040311 ()
1116728

  • CPAP/BPAP nasal mask, reusable
DreamWear Under Nose Mask, Wide, S Frame w/Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, Wide, S Frame w/Headgear, JP
Not in Commercial Distribution

  • 00606959040298 ()
1116724

  • CPAP/BPAP nasal mask, reusable
Wisp Nasal Mask with Headgear, Fabric Frame, Small Medium, Japan
Respironics, Inc.
Wisp Nasal Mask w/Headgear, Fabric Frame, Sm/Med, JP
Not in Commercial Distribution

  • 00606959040120 ()
1094072

  • CPAP/BPAP nasal mask, reusable
BiPAP Auto BiFlex with Humidifier, System One 60 Series, Japan
Respironics, Inc.
BiPAP Auto BiFlex w/Humid System One 60 Series, JP
Not in Commercial Distribution

  • 00606959031852 ()
JP766HS

  • Home BPAP unit
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