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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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Mediblu - B632MDB01003

No Description
MEDIBLU MEDICAL LLC
MM12
In Commercial Distribution

  • B632MDB01003 ()
MDB01003

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01001

No Description
MEDIBLU MEDICAL LLC
MM17
In Commercial Distribution

  • B632MDB01001 ()
MDB01001

  • Multiple vital physiological parameter monitoring system, clinical

Omni™ Surgical Suite Platform - 00889024647343

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024647343 ()
AI1000

  • Medical image management system

NOGA XP - 10846835011678

NOGA XP-Cardiac Mapping System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG170000
Not in Commercial Distribution

  • 10846835011678 ()
FG170000

  • Cardiac mapping system

CARTO 3 - 10846835000870

CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

  • Cardiac mapping system

NA - 00840682124591

MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software

EchoPAC - 00840682123518

No Description
GE Vingmed Ultrasound AS
Plug-in v202
In Commercial Distribution

  • 00840682123518 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682123501

No Description
GE Vingmed Ultrasound AS
Software Only v202
In Commercial Distribution

  • 00840682123501 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682121095

No Description
GE Vingmed Ultrasound AS
Software Only v113
In Commercial Distribution

  • 00840682121095 ()


  • Ultrasound imaging system application software

Optima - 00840682115278

No Description
GE MEDICAL SYSTEMS, INC.
XR200amx
In Commercial Distribution

  • 00840682115278 ()


  • Portable basic diagnostic x-ray system, digital

CARESCAPE - 00840682109833

CARESCAPE CENTRAL STATION V1 UPGRADE KIT FROM CIC V5 ON MP100
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1 upgrade
Not in Commercial Distribution

  • 00840682109833 ()


  • Centralized patient monitor

CARESCAPE Central Station - 00840682109604

CARESCAPE CENTRAL STATION V2 MAS 700 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V2 Standard MAS 700
Not in Commercial Distribution

  • 00840682109604 ()


  • Centralized patient monitor

CENTRICITY - 00840682145794

No Description
GE HEALTHCARE
UNIVERSAL VIEWER 7.0
In Commercial Distribution

  • 00840682145794 ()


  • Medical image management system

Vscan - 00840682147101

Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software

Vscan - 00840682147071

Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682146883

No Description
GE Vingmed Ultrasound AS
Software Only v204
In Commercial Distribution

  • 00840682146883 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682146876

No Description
GE Vingmed Ultrasound AS
Plug-in v204
In Commercial Distribution

  • 00840682146876 ()


  • Ultrasound imaging system application software

CARESCAPE - 00840682144292

V100 GENERIC ATO MODEL No CE
Ge Medical Systems Information Technologies, Inc.
V100
Not in Commercial Distribution

  • 00840682144292 ()


  • Multiple vital physiological parameter monitoring system, clinical

EchoPAC - 00840682141703

No Description
GE Vingmed Ultrasound AS
Software Only v203
In Commercial Distribution

  • 00840682141703 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682141697

No Description
GE Vingmed Ultrasound AS
Plug-in v203
In Commercial Distribution

  • 00840682141697 ()


  • Ultrasound imaging system application software
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