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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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EasyMax 15 NHCS Set EN - 00885017000560

a bottle of level 2 control solution
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 10885017000567 ()
  • 00885017000560 ()


  • Glucose IVD, control

EasyMax NHCS Set EN - 00885017000553

1 bottle of Level 2 Solution
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

  • 10885017000550 ()
  • 00885017000553 ()


  • Glucose IVD, control

FortisCare Self-Monitoring Blood Glucose System - 00885017000461

1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience kit
EPS BIO TECHNOLOGY CORP.
EM66
Not in Commercial Distribution

  • 00885017000461 ()
  • 01885017000460 ()
  • 10885017000468 ()


  • Glucose monitoring system IVD, home-use

FortisCare Blood Glucose Test Strip - 00885017000447

50 strips in a vial
EPS BIO TECHNOLOGY CORP.
EM44
Not in Commercial Distribution

  • 00885017000447 ()
  • 01885017000446 ()


  • Glucose IVD, kit, electrometry

EASYMAX T1 Self-Monitoring Blood Glucose System - 00885017000409

1 blood glucose meter; 25 ct. Foiled Pack Test Strips; 10 Lancets, 1 Lancing device in a convenience kit.
EPS BIO TECHNOLOGY CORP.
EasyMax T1 Pro
In Commercial Distribution

  • 00885017000409 ()
  • 10885017000406 ()


  • Glucose monitoring system IVD, home-use

EasyMax Blood Glucose Test Strip - 00885017000355

10 strips in a vial
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

  • 00885017000355 ()
  • 01885017000354 ()
  • 10885017000352 ()


  • Glucose IVD, kit, electrometry

EasyMax NG Self-Monitoring Blood Glucose System - 00885017000324

1 blood glucose meter; 10 strips in a vial; level 2 control solution, 10 lancets, 1 lancing device in a convenience kit. 1 blood glucose meter; 10 strips in a vial; level 2 control solution, 5 lancets, 1 lancing device in a convenience kit. (10885017000321)
EPS BIO TECHNOLOGY CORP.
EMMU
In Commercial Distribution

  • 00885017000324 ()
  • 01885017000323 ()
  • 10885017000321 ()


  • Glucose monitoring system IVD, home-use

25 EasyMax FTS Set EN-ES - 00885017000270

The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EPS BIO TECHNOLOGY CORP.
EASY MAX
In Commercial Distribution

  • 10885017000277 ()
  • 00885017000270 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid

EasyMax V Self-Monitoring Blood Glucose System - 00885017000058

one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMV
In Commercial Distribution

  • 00885017000058 ()
  • 01885017000057 ()
  • 10885017000055 ()


  • Glucose monitoring system IVD, home-use

EasyMax Blood Glucose Test Strip - 00885017000010

50 strips in a vial
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

  • 00885017000010 ()
  • 01885017000019 ()
  • 10885017000017 ()


  • Glucose IVD, kit, electrometry
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