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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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In Touch Refill Kit - 00853553005103

6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005103 ()
KIT00147

  • Blood lancing device tip
  • Glucose IVD, control
  • Glucose IVD, reagent

In Touch Welcome Kit - 00853553005097

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 Sterile Lancets - 00853553005066

Box of 100 Sterile Lancets
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005066 ()
OFG00142

  • Blood lancing device tip

Inb Touch Lancing Device - 00853553005059

Box of 1 Lancet Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005059 ()
OFG00141

  • Manual blood lancing device, reusable

In Touch Glucose Control Solutions - 00853553005028

Box of High/Low Control Solution
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005028 ()
OFG00140

  • Glucose IVD, control

InHealth Technologies; Blom-Singer - 00813307014744

No Description
Freudenberg Medical, LLC
IN 4066
In Commercial Distribution

  • 00813307014744 ()
  • 00848253002682 ()


  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer - 00813307014737

No Description
Freudenberg Medical, LLC
IN 4065
In Commercial Distribution

  • 00813307014737 ()
  • 00848253002675 ()


  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer - 00813307014720

No Description
Freudenberg Medical, LLC
IN 4064
In Commercial Distribution

  • 00813307014720 ()
  • 00848253002668 ()


  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307014577

No Description
Freudenberg Medical, LLC
IN 1612-IR
In Commercial Distribution

  • 00813307014577 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307014560

No Description
Freudenberg Medical, LLC
IN 1610-IR
In Commercial Distribution

  • 00813307014560 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive
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