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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Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5503-06-300
In Commercial Distribution

  • 00817491024268 ()
FG-5503-06-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491023605 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491022370 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution

  • 00817491020819 ()
FG-5500-01-300

  • Implantable glucose monitoring system
DRUGS OF ABUSE 1
UTAK LABORATORIES, INC.
DA 1 WB VTS
In Commercial Distribution

  • B800DA1WBVTS5 ()
  • B800DA1WBVTS0 ()

  • Total Volume: 25 Milliliter
DA 1 WB VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZOYLECGONINE 1
UTAK LABORATORIES, INC.
BE M 1 VTS
In Commercial Distribution

  • B800BEM1VTS5 ()
  • B800BEM1VTS0 ()

  • Total Volume: 25 Milliliter
BE M 1 VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE PLUS
UTAK LABORATORIES, INC.
MOR+ U F VTS
In Commercial Distribution

  • B800MORUFVTS5 ()
  • B800MORUFVTS0 ()

  • Total Volume: 2 Milliliter
MOR+ U F VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution

  • 00850049194037 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution

  • 00850049194013 ()


  • Air-conduction hearing aid, receiver-in-canal
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
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