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 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
BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, JP
Not in Commercial Distribution

  • 00606959038202 ()
966P

  • Portable electric ventilator
Li Ion Battery, Ventilation, rechargable battery pack, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959033344 ()
1126945

  • Portable/mobile rechargeable battery pack
System One Heated Humidifier with Tube Assembly, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959032125 ()
JP6TFLG

  • Heated respiratory humidifier
BiPAP A Series, System One Heated Humidifier, Japan
Respironics, Inc.
BiPAP A Series, System One Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959032064 ()
1111548

  • Heated respiratory humidifier
REMstar Pro C-Flex+, System One 60 Series, Japan
Respironics, Inc.
REMstar Pro C-Flex+, System One 60Series, JP
Not in Commercial Distribution

  • 00606959030466 ()
JP466S

  • Home CPAP unit
BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, JP
Not in Commercial Distribution

  • 00606959029743 ()
JP966S

  • Portable electric ventilator
OmniLab Advanced Plus with Heated Tube Humidifier, Japan
Respironics, Inc.
OmniLab Advanced Plus w/H Tube Humid, JP
Not in Commercial Distribution

  • 00606959029460 ()
1111140

  • Portable electric ventilator
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