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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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Arterys Inc.
AMM6
Not in Commercial Distribution

  • B664AMM60 ()


  • Radiology DICOM image processing application software
The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios Mobile Application receives and displays patient physiological and waveform data and alarms generated by Vios’ proprietary patient vitals monitoring software. The Vios Mobile Application is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
VMM2050 Mobile Application
In Commercial Distribution

  • B595VMM2050 ()
VMM2050

  • Cardiac arrhythmia monitoring system
  • Clinical management support software
Bolt EIA-CLIA (refurbished)
Gold Standard Diagnostics Corporation
00500-CLR
In Commercial Distribution

  • B35000500CLR0 ()
00500-CLR

  • Chemiluminescent immunoassay analyser IVD
  • Enzyme immunoassay (EIA) analyser IVD
Bolt EIA-CLIA
Gold Standard Diagnostics Corporation
00500-CL
In Commercial Distribution

  • B35000500CL0 ()
00500CL

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD
ThunderBolt EIA-CLIA (refurbished)
Gold Standard Diagnostics Corporation
00300-CLR
In Commercial Distribution

  • B35000300CLR0 ()
00300-CLR

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD
ThunderBolt EIA-CLIA
Gold Standard Diagnostics Corporation
00300-CL
In Commercial Distribution

  • B35000300CL0 ()
00300CL

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD
DCTclock System
Linus Health, Inc.
1110
In Commercial Distribution

  • B62611100 ()
1110

  • Drawing-test cognitive function analysis device
DCTclock System - Research
Linus Health, Inc.
10096
In Commercial Distribution

  • B626100960 ()
10096

  • Drawing-test cognitive function analysis device
DCTclock Practice Test Form - clinical
Linus Health, Inc.
10093
In Commercial Distribution

  • B626100931 ()
  • B626100930 ()
10093

  • Drawing-test cognitive function analysis device
DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

  • B626100722 ()
  • B626100721 ()
  • B626100720 ()
10072

  • Drawing-test cognitive function analysis device
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