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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FitLife Mask with Headgear, Extra Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, Extra Large, Japan
Not in Commercial Distribution

  • 00606959023048 ()
1089996

  • CPAP/BPAP face mask, reusable
DreamStation BiPAP autoSV with cellular modem, Japan
Respironics, Inc.
DreamStation BiPAP autoSV W/Cell, JP
Not in Commercial Distribution

  • 00606959045415 ()
JPX900S16C

  • Portable electric ventilator
ComfortGel Blue Full Mask, Extra Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Extra Large, Japan
Not in Commercial Distribution

  • 00606959043909 ()
1081843

  • CPAP/BPAP face mask, reusable
BiPAP A40 Silver Series FGD SA, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959042797 ()
1109601

  • Portable electric ventilator
Nuance Gel Pillows Mask with headgear, Japan
Respironics, Inc.
Nuance Gel Pillows Mask with headgear, Japan
Not in Commercial Distribution

  • 00606959041905 ()
1105162

  • CPAP/BPAP nasal mask, reusable
EasyLife Mask with Headgear, Medium Wide, Japan
Respironics, Inc.
EasyLife Mask w/Headgear, Medium Wide, Japan
Not in Commercial Distribution

  • 00606959027862 ()
1050043

  • CPAP/BPAP nasal mask, reusable
DreamStation Go Auto CPAP with Bluetooth, Japan
Respironics, Inc.
DreamStation Go Auto CPAP with Bluetooth, JP
Not in Commercial Distribution

  • 00606959048706 ()
JPG500S16

  • Home CPAP unit
PN841 Mask, Child Large, Leak 3, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Large, Leak 3, ASM
In Commercial Distribution

  • 30606959041623 ()
  • 00606959041622 ()
1130560

  • CPAP/BPAP nasal mask, single-use
PN841 Mask, Child Med, Leak 3, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, Leak 3, ASM
In Commercial Distribution

  • 30606959041616 ()
  • 00606959041615 ()
1130558

  • CPAP/BPAP nasal mask, single-use
PN841 Mask, Child Small, Leak 3, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Small, Leak 3, ASM
Not in Commercial Distribution

  • 30606959041609 ()
  • 00606959041608 ()
1130496

  • CPAP/BPAP nasal mask, single-use
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