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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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Eversense CGM Mobile Application (Android) 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-5600-01-300
Not in Commercial Distribution

  • 00817491020826 ()
FG-5600-01-300

  • 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
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software
SFTWR MMT-6121 FOTA ANDROID V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6121
In Commercial Distribution

  • 00763000532161 ()


  • Patient health record information system application software
+ DAMON CLR SPK U/L 5-5 STD-TQ W. CLR U/L 3-3
ORMCO CORPORATION
740-1407
In Commercial Distribution

  • 00889989080483 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic
+ DAMON CLR SPK U/L 7-7 STD-TQ W. CLR U/L 3-3
ORMCO CORPORATION
740-1406
In Commercial Distribution

  • 00889989080476 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic
bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 4 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 7 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2002
In Commercial Distribution

  • 00867622000456 ()
  • 00867622000470 ()
SK-2002

  • Enteral feeding kit, adult/paediatric, non-sterile
bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2001
In Commercial Distribution

  • 00867622000449 ()
  • 00867622000463 ()
SK-2001

  • Enteral feeding kit, adult/paediatric, non-sterile
Large Cap Gravity Feeding Set with ENFit Connector
U DELIVER MEDICAL L.L.C.
1405
In Commercial Distribution

  • 00867622000418 ()
  • 10867622000415 ()
1405

  • Enteral feeding kit, adult/paediatric, non-sterile
Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector
U DELIVER MEDICAL L.L.C.
1085
In Commercial Distribution

  • 00867622000401 ()
  • 10867622000408 ()
  • 20867622000405 ()
1085

  • Enteral feeding kit, adult/paediatric, non-sterile
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