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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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Revolution Apex - 00195278788665

Revolution Apex Select with Plus Edition - Designated System Medical Device
Hangwei GE Medical Systems Co., Ltd.
Select with Plus Edition
In Commercial Distribution

  • 00195278788665 ()
B7919YO

  • Full-body CT system

Aisys - 00195278588128

AISYS CS2 WITH ET CONTROL
DATEX-OHMEDA INC
CS2 WITH ET CONTROL
In Commercial Distribution

  • 00195278588128 ()


  • Anaesthesia workstation, general-purpose

Revolution CT - 00195278471277

Revolution CT ES with Apex edition - Designated System Medical Device
GE MEDICAL SYSTEMS, INC.
ES with Apex edition
In Commercial Distribution

  • 00195278471277 ()
5826588

  • Full-body CT system

MasterScope - 04057155000641

diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope WSSU with ECG
In Commercial Distribution

  • 04057155000641 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel

MasterScope - 04057155000627

diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope CT with ECG
In Commercial Distribution

  • 04057155000627 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel

MasterScope - 04057155000030

diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope CT with ECG
In Commercial Distribution

  • 04057155000030 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel

Vivid - 00840682146692

No Description
GE Vingmed Ultrasound AS
E90 v204 with LCD
In Commercial Distribution

  • 00840682146692 ()


  • Cardiovascular ultrasound imaging system

Vivid - 00840682146685

No Description
GE Vingmed Ultrasound AS
E95 v204 with LCD
In Commercial Distribution

  • 00840682146685 ()


  • Cardiovascular ultrasound imaging system

Vivid - 00840682146678

No Description
GE Vingmed Ultrasound AS
E90 v204 with OLED
In Commercial Distribution

  • 00840682146678 ()


  • Cardiovascular ultrasound imaging system

Vivid - 00840682146661

No Description
GE Vingmed Ultrasound AS
E80 v204 with LCD
In Commercial Distribution

  • 00840682146661 ()


  • Cardiovascular ultrasound imaging system
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