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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Trilogy 200 Ventilator, Bluetooth, Japan
Respironics, Inc.
Trilogy 200 Ventilator, Bluetooth, Japan
Not in Commercial Distribution

  • 00606959052352 ()
1032804B

  • Portable electric ventilator
DreamStation Auto CPAP, 12mm, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959061316 ()
JPX501S16

  • Home CPAP unit
Software, Sleepware G3 (Japan Only)
Respironics, Inc.
Sleepware G3 Software, (Japan Only) - 3
Not in Commercial Distribution

  • 00606959046955 ()
1121998

  • Polysomnography analyser
Sleepware G3 Software Package, Japan
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959038943 ()
1121998

  • Polysomnography analyser
BiPAP Hybrid A30 Ventilator, Japan
Respironics, Inc.
BiPAP Hybrid A30 Ventilator, Japan
Not in Commercial Distribution

  • 00606959038110 ()
1111181

  • Portable electric ventilator
Trilogy O2 Ventilator, Recertified, Japan
Respironics, Inc.
Trilogy O2 Ventilator,Japan-RECERT
Not in Commercial Distribution

  • 00606959033948 ()
U1040004

  • Portable electric ventilator
Trilogy 100 Ventilator, Japan, Rental
Respironics, Inc.
00
In Commercial Distribution

  • 00606959033894 ()
R1054655

  • Portable electric ventilator
Trilogy O2 Ventilator, Rental, Japan
Respironics, Inc.
Trilogy O2 Ventilator, Japan, Rental
Not in Commercial Distribution

  • 00606959033887 ()
R1040004

  • Portable electric ventilator
System One Heated Humidifier, Japan
Respironics, Inc.
System One Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959032101 ()
JP6HFLG

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

  • 00606959029248 ()
JP6H

  • Heated respiratory humidifier
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