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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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Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1465A
Not in Commercial Distribution

  • 40301931465509 ()
  • 00301931465501 ()
  • 10301931465508 ()
  • 20301931465505 ()
  • 0193-1465-50 ()
  • 00301931465013 ()
56853212

  • Glucose monitoring system IVD, home-use
No Description
Roche Diagnostics GmbH
08445672190
Not in Commercial Distribution

  • 07613336157817 ()
08445672190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
08057630190
In Commercial Distribution

  • 07613336121221 ()
08057630190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
08057427190
In Commercial Distribution

  • 07613336121092 ()
08057427190

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Heartrak ECAT 2
In Commercial Distribution

  • B147HTECAT020 ()


  • Electrocardiography telemetric monitoring system
No Description
Sonova AG
2.1
In Commercial Distribution

  • 07613389652536 ()
088-0025-00021

  • Audiometric/hearing device software
No Description
Sonova AG
2.2
In Commercial Distribution

  • 07613389700657 ()
088-0025-00022

  • Audiometric/hearing device software
No Description
Sonova AG
2.0
In Commercial Distribution

  • 07613389652529 ()
088-0025-00020

  • Audiometric/hearing device software
No Description
Sonova AG
2.3
In Commercial Distribution

  • 07613389700671 ()
088-0025-00023

  • Audiometric/hearing device software
No Description
Roche Diagnostics GmbH
08056714190
In Commercial Distribution

  • 07613336120958 ()
08056714190

  • Albumin IVD, kit, spectrophotometry
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