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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I-neb PH Unit Japan
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730004396 ()
1080086

  • Ultrasonic nebulizing system
AC Power Cord, Japan
OSTEOMED LLC
450-0537
In Commercial Distribution

  • 00845694012782 ()
450-0537

  • General internal orthopaedic fixation system implantation kit
PRI Cellular Modem, Japan
Respironics, Inc.
PRI Cellular Modem, JA
Not in Commercial Distribution

  • 00606959026704 ()
100230C

  • Clinical laboratory information system
Trilogy O2 Ventilator, Japan
Respironics, Inc.
Trilogy O2 Ventilator Japan
Not in Commercial Distribution

  • 00606959025394 ()
1040004

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

  • 00606959025387 ()
1054655

  • Portable electric ventilator
Trilogy 200 Ventilator, Japan
Respironics, Inc.
Trilogy200 Ventilator, Japan
Not in Commercial Distribution

  • 00606959025370 ()
1032804

  • Portable electric ventilator
DreamStation Cellular Modem, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959022881 ()
100630C

  • Clinical laboratory information system
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
DreamStation Auto CPAP, Japan
Respironics, Inc.
DreamStation Auto CPAP, JP
Not in Commercial Distribution

  • 00606959028265 ()
JPX500S16

  • Home CPAP unit
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