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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ComfortGel Blue Nasal Mask w/Headgear, Petite, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Petite, Japan
Not in Commercial Distribution

  • 00606959043763 ()
1070085

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask w/Headgear, Small, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959043756 ()
1070084

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask w/Headgear, Medium, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Medium, Japan
Not in Commercial Distribution

  • 00606959043749 ()
1070083

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask w/Headgear, Large, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959043732 ()
1070082

  • CPAP/BPAP nasal mask, reusable
Nuance Pro Gel Pillows Mask with headgear, Japan
Respironics, Inc.
Nuance Pro Gel Pillows Mask with headgear, Japan
Not in Commercial Distribution

  • 00606959041868 ()
1105169

  • CPAP/BPAP nasal mask, reusable
PN841 Mask with Standard Elbow, Child Large, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Large, SE, ASM
In Commercial Distribution

  • 30606959041654 ()
  • 00606959041653 ()
1130566

  • CPAP/BPAP nasal mask, single-use
PN841 Mask with Standard Elbow, Child Med, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, SE, ASM
In Commercial Distribution

  • 30606959041647 ()
  • 00606959041646 ()
1130564

  • CPAP/BPAP nasal mask, single-use
PN841 Mask with Standard Elbow, Child Small, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Small, SE, ASM
In Commercial Distribution

  • 30606959041630 ()
  • 00606959041639 ()
1130562

  • CPAP/BPAP nasal mask, single-use
A Series System One Heated Tube Humidifier, Japan
Respironics, Inc.
A Series System One Heated Tube Humidifier, Japan
In Commercial Distribution

  • 00606959041035 ()
1111556

  • Heated respiratory humidifier
BiPAP A40 Ventilatory Support System Silver Series, Japan
Respironics, Inc.
BiPAP A40 Silver Series Ventilator, JP
Not in Commercial Distribution

  • 00606959039544 ()
1111177

  • Portable electric ventilator
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