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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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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
INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT
IBSA FARMACEUTICI ITALIA SRL
GS3111
In Commercial Distribution

  • 08033638951057 ()
  • 89130-3111-1 ()

  • Total Volume: 2.25 Milliliter


  • Synovial fluid supplementation medium
Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).
ASCENSIA DIABETES CARE US INC.
7312
In Commercial Distribution

  • 40301939737219 ()
  • 00301937312212 ()
  • 10301937312219 ()
  • 40301937312210 ()
  • 0193-7312-21 ()
  • 00301937312014 ()
  • 40301935541049 ()
  • 40301939770513 ()
83624788

  • Glucose monitoring system IVD, home-use
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
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
020-994
In Commercial Distribution

  • 20353885994259 ()
  • 00353885994255 ()
  • 80353885994251 ()
  • 53885-994-25 ()
020-994

  • Glucose IVD, kit, electrometry
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
022-896
In Commercial Distribution

  • 20353885009724 ()
  • 00353885009720 ()
  • 80353885009726 ()
  • 53885-244-50 ()
022-896

  • Glucose IVD, kit, electrometry
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
022-895
In Commercial Distribution

  • 20353885009717 ()
  • 00353885009713 ()
  • 80353885009719 ()
  • 53885-245-10 ()
022-895

  • Glucose IVD, kit, electrometry
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
020-963
In Commercial Distribution

  • 20353885004187 ()
  • 00353885004183 ()
  • 80353885004189 ()
  • 30353885004184 ()
  • 53885-963-50 ()
020-963

  • Glucose IVD, kit, electrometry
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
ASCENSIA DIABETES CARE US INC.
9628
Not in Commercial Distribution

  • 40301939628012 ()
  • 00301939628014 ()
  • 0193-9628-01 ()
83785544

  • Glucose monitoring system IVD, home-use
Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution

  • 0193-6262-01 ()
  • 00301936262013 ()
85092979

  • Glucose monitoring system IVD, home-use
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