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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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The SecurView® RT technologist workstation Manager provides central database access and performs the image preparation for all connected SecurView RT Client workstations.
Hologic, Inc.
SVRT Manager
In Commercial Distribution

  • 15420045507371 ()
SVRT-00600R

  • Laboratory instrument/analyser application software IVD
The SecurView® RT technologist workstation is intended to be used by technologists to view images durign screening and diagnostic exams.
Hologic, Inc.
SVRT
In Commercial Distribution

  • 15420045507364 ()
SVRT-00300

  • Laboratory instrument/analyser application software IVD
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
SWEETSPOT DIABETES CARE, INC.
350-0010
Not in Commercial Distribution

  • B059POW3500010 ()
350-0010

  • Noninvasive interstitial-fluid glucose monitoring device
Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to assist people with diabetes in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities. With RCP, it provides additional administrative features for use by Clinicians to access Dexcom CLARITY reports (digital or print) for their patients with diabetes. These features do not change the intended use of CLARITY. They improve the usefulness of it from the clinician perspective.
SWEETSPOT DIABETES CARE, INC.
350-0011
Not in Commercial Distribution

  • B059CLARITY35000011 ()
350-0011

  • Noninvasive interstitial-fluid glucose monitoring device
LibreView
ABBOTT DIABETES CARE INC
72156-01
In Commercial Distribution

  • 00357599823009 ()
72156-01

  • Self-care monitoring/reporting software
LibreViewGov
ABBOTT DIABETES CARE INC
72157-01
In Commercial Distribution

  • 00357599826000 ()
72157-01

  • Self-care monitoring/reporting software
Tandem Source Web Application v 3.X
Tandem Diabetes Care, Inc.
1011061
In Commercial Distribution

  • 00389152106113 ()
1011061

  • Ambulatory insulin infusion pump software, data-display
Public API that allows access by authorized third parties to select Dexcom data
Dexcom, Inc.
SW13183
In Commercial Distribution

  • 00386270000668 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
No Description
Sugarmate, LLC
1008182
In Commercial Distribution

  • 00850018992626 ()


  • Self-care monitoring/reporting software
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