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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DreamStation CPAP Pro with Cell, Japan
Respironics, Inc.
DreamStation CPAP Pro w/Cell, JP
Not in Commercial Distribution

  • 00606959034761 ()
JPX400S16C

  • Home CPAP unit
Trilogy 100 Ventilator, Recertified, Japan version
Respironics, Inc.
00
In Commercial Distribution

  • 00606959033955 ()
U1054655

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

  • 00606959033863 ()
R1032804

  • Portable electric ventilator
Alice 6 Base Station, LDx, Japan
Respironics, Inc.
Alice 6 Base Station, LDx, Japan
Not in Commercial Distribution

  • 00606959033764 ()
JP1063315

  • Polysomnograph
Alice 6 Base Station, LDE, Japan
Respironics, Inc.
Alice 6 Base Station, LDE, Japan
Not in Commercial Distribution

  • 00606959033757 ()
JP1063312

  • Polysomnograph
Alice PDx, ECG Yoke Cable, Japan
Respironics, Inc.
Alice PDx ECG Yoke, JP
Not in Commercial Distribution

  • 00606959033580 ()
1048916

  • Polysomnograph
OmniLab Advanced Plus with Humidifier, Japan
Respironics, Inc.
OmniLab Advanced Plus with Humidifier, JP
Not in Commercial Distribution

  • 00606959029453 ()
1111139

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

  • 00606959029255 ()
JP6T

  • Heated respiratory humidifier
ENDOVUE, 24", AMERICAS, JAPAN, EMEA, BC-WU24-N1418
Nds Surgical Imaging LLC
90K0076
Not in Commercial Distribution

  • 00818089022956 ()


  • Image display unit, colour
ENDOVUE, 21", AMERICAS, JAPAN, EMEA, BC-WU21-N1418
Nds Surgical Imaging LLC
90K0066
Not in Commercial Distribution

  • 00818089022949 ()


  • Image display unit, colour
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