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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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BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish)
LIVONGO HEALTH, INC
Livongo G2.0FW2.1
In Commercial Distribution

  • 00853553005295 ()
KIT00801

  • Glucose monitoring system IVD, home-use
Livongo BG300 Blood Glucose Meter
LIVONGO HEALTH, INC
BG300
In Commercial Distribution

  • 00853553005288 ()
FG00688

  • Glucose analyser IVD, home-use/point-of-care, line-powered
Livongo Demo Kit with BG300, 1 vial of Livongo Test strips, 1 bag of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish)
LIVONGO HEALTH, INC
Livongo
In Commercial Distribution

  • 00853553005271 ()
KIT00425

  • Glucose monitoring system IVD, home-use
Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)
LIVONGO HEALTH, INC
Livongo
In Commercial Distribution

  • 00853553005240 ()
KIT00423

  • Home-use/point-of-care glucose analyser IVD, battery-powered
Livongo Welcome Kit G2.0 with BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low,1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish)
LIVONGO HEALTH, INC
Livongo G2.0
In Commercial Distribution

  • 00853553005233 ()
KIT00421

  • Glucose monitoring system IVD, home-use
Livongo BG300 Blood Glucose Meter
LIVONGO HEALTH, INC
BG300
In Commercial Distribution

  • 00853553005196 ()
FG00408

  • Glucose analyser IVD, home-use/point-of-care, line-powered
In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxes of In Touch Test Strips, 1 In Touch Lancing Device, 3 boxes of sterile In Touch Lancets, 1 Carrying Case, 1 Charger, 1 Charger cable, 1 Instructions for Use (English and Spanish), About Guide (English and Spanish)
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005097 ()
KIT00145

  • Glucose monitoring system IVD, home-use
In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable
LIVONGO HEALTH, INC
BG200
In Commercial Distribution

  • 00853553005035 ()
FG00163

  • Home-use/point-of-care glucose analyser IVD, battery-powered
BG300 rev C Blood Glucose Meter, Kaifa DongGuan
LIVONGO HEALTH, INC
BG300C, Kaifa DongGuan
In Commercial Distribution

  • 00853553005011 ()
FG02062

  • Glucose analyser IVD, home-use
VivaGuard Ino Smart Blood Glucose Meter
Able Diagnostics Inc
VGM04
In Commercial Distribution

  • 00853483008243 ()


  • Glucose IVD, kit, electrometry
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