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

  • 00885017000447 ()
  • 01885017000446 ()


  • Glucose IVD, kit, electrometry
50 strips in a vial
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 00885017000416 ()
  • 01885017000415 ()
  • 10885017000413 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
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
a bottle of level 1 control solution
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 00885017000362 ()
  • 01885017000361 ()


  • Glucose IVD, control
10 strips in a vial
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

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


  • Glucose IVD, kit, electrometry
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
The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.
EPS BIO TECHNOLOGY CORP.
EASY MAX 15
In Commercial Distribution

  • 10885017000284 ()
  • 00885017000287 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
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
10 strips in a vial
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 01885017000170 ()
  • 00885017000171 ()
  • 10885017000178 ()


  • Glucose IVD, kit, electrometry
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