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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SimplyGoMini, Standard Battery, Japan
Respironics, Inc.
SimplyGo Mini, Standard Battery, JP
Not in Commercial Distribution

  • 00606959047440 ()
1133943

  • Mobile/portable oxygen concentrator
Actiwatch Spectrum Plus Japan
Respironics, Inc.
Actiwatch Spectrum Plus, Japan
Not in Commercial Distribution

  • 00606959042049 ()
JP1101894

  • Kinesiology ambulatory recorder
DreamStation Heated Humidifier, Japan
Respironics, Inc.
DreamStation Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959033368 ()
JPXH

  • Heated respiratory humidifier
OmniLab Advanced Plus, Japan
Respironics, Inc.
OmniLab Advanced Plus, JP
Not in Commercial Distribution

  • 00606959032040 ()
1109585

  • Portable electric ventilator
OmniLab Advanced Plus, Japan
Respironics, Inc.
OmniLab Advanced Plus, JP
Not in Commercial Distribution

  • 00606959029446 ()
1111138

  • Portable electric ventilator
DreamStation Auto BiPAP, Japan
Respironics, Inc.
DreamStation Auto BiPAP, JP
Not in Commercial Distribution

  • 00606959028272 ()
JPX700S16

  • Home BPAP unit
DreamStation Auto CPAP, Japan
Respironics, Inc.
DreamStation Auto CPAP, JP
Not in Commercial Distribution

  • 00606959028265 ()
JPX500S16

  • Home CPAP unit
DreamStation CPAP Pro, Japan
Respironics, Inc.
DreamStation CPAP Pro, JP
In Commercial Distribution

  • 00606959028258 ()
JPX400S16

  • Home CPAP unit
Broadband Oximetry Accessory, Japan
Respironics, Inc.
Broadband/Oximetry Accessory, JP
Not in Commercial Distribution

  • 00606959028197 ()
100225E

  • Clinical laboratory information system
CO2RE System, Packaged (Japan)
Candela Corporation
FG70412JP
In Commercial Distribution

FG70412JP

  • Dermatological carbon dioxide laser system
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