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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Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
Unistrip Technologies, LLC
038600
In Commercial Distribution

  • 00681131304863 ()
  • 00681131104869 ()
  • 90681131104862 ()
  • 30681131104860 ()
  • 10681131104866 ()
  • 49035-0386-00 ()
038600

  • Glucose IVD, kit, electrometry
Blood Glucose Test strips. 25 test strips.
ASCENSIA DIABETES CARE US INC.
7070A
Not in Commercial Distribution

  • 40301939725254 ()
  • 00301937070259 ()
  • 10301937070256 ()
  • 40301937070257 ()
  • 0193-7070-25 ()
  • 00301937070013 ()
6707105

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE blood glucose meter; 10 CONTOUR® NEXT blood glucose test strips; Lancing Device; 10 Colored MICROLET® lancets (provided sterile); User Guide (including CONTOUR® DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT control solution. A clear endcap is available for Alternative Site Testing (AST). It may not be included in your meter kit. If you perform AST and need a clear endcap (for palm), contact Diabetes Care Customer Service.
ASCENSIA DIABETES CARE US INC.
9767
Not in Commercial Distribution

  • 40301939767018 ()
  • 00301939767010 ()
  • 0193-9767-01 ()
85977059

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908964 ()
  • 08809115908957 ()
  • 8522-0000-64 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908438 ()
  • 8522-0000-23 ()
  • 08809115908445 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry
Control Solution - Level 2. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
7314
In Commercial Distribution

  • 50301937314013 ()
  • 40301937314016 ()
  • 00301937314018 ()
  • 10301937314015 ()
  • 0193-7314-01 ()
83624818

  • Glucose IVD, control
G5 Touchscreen Receiver
Dexcom, Inc.
STK-SR-001
Not in Commercial Distribution

  • 20386270000327 ()
  • 08627-0090-11 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G6 Receiver Kit (Retail)
Dexcom, Inc.
STK-OE-001
In Commercial Distribution

  • 00386270001900 ()
  • 08627-0091-11 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
78754
In Commercial Distribution

  • 30357599842001 ()
  • 00357599842000 ()
  • 57599-0842-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 Plus Sensor Not For Retail Sale
ABBOTT DIABETES CARE INC
78749
In Commercial Distribution

  • 30357599836000 ()
  • 00357599836009 ()
  • 57599-0836-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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