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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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FACS - 00382906577658

BD FACS™ Sample Prep Assistant III Software
Becton, Dickinson And Company
657765
In Commercial Distribution

  • 00382906577658 ()
657765

  • Laboratory instrument/analyser application software IVD

4Klearity - 00817613021021

4Klearity Med X Change Brand Software Version 7.12.1.2
Nds Surgical Imaging LLC
4KR100
Not in Commercial Distribution

  • 00817613021021 ()


  • Endoscopic video image processing unit

VP2000 - 00884999048478

VP 2000 System Software v2.1 with Protocols USB
ABBOTT MOLECULAR INC.
02J11-057
In Commercial Distribution

  • 00884999048478 ()
02J11-057

  • Tissue processor IVD, automated/semi-automated

HexaVue - 00724995220594

HexaVue IP In-Light Camera Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220594 ()
XQHPILCC

  • Operating room audiovisual data/device management system application software

Cornerstones4Care® Powered by Glooko Mobile Application - 00855093008040

Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, insulin pumps and continuous glucose monitors
GLOOKO, INC.
1.xx
Not in Commercial Distribution

  • 00855093008040 ()


  • Clinical management support software

Glooko Mobile Application - 00855093008033

The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software

Glooko Web Application - 00855093008026

Glooko Web Application is a web based application that displays and analyzes retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
xx.yy (xx is model year and yy is a serial number)
In Commercial Distribution

  • 00855093008026 ()


  • Clinical management support software

Mediworks - 06945087505175

No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser

wtATTR-CM AcceleraTTR™ - 05415062388310

Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution

  • 05415062388310 ()


  • Cardiovascular interpretive screening software

VinehealthPRO - 05070000764122

No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution

  • 05070000764122 ()


  • Clinical management support software
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