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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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Portrait CSS01 - 00195278341129

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software

Portrait CVA01 - 00195278330413

PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only

SenoIris - 00840682147767

SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation

SenoIris - 00840682140614

SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation

Radixact™ Treatment Delivery System - M65810602530

Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system

Vita CR System - 60889971919878

IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

  • Computed radiography digital imaging scanner

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE - B1623181

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct

AirStrip OB Legacy iOS - B15310010

OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter

AirStrip OB Legacy Server - B15310000

OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter

UNITRON - 07613389221589

TrueFit v3.7 DVD Software Package USA
Unitron Hearing Division
058-5229
In Commercial Distribution

  • 07613389221589 ()
058-5229

  • Audiometric/hearing device software
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