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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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HeartStart FR3 Defibrillator
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart FR3
In Commercial Distribution

  • 00884838049994 ()
861389

  • Rechargeable professional automated external defibrillator
HeartStart FR3 Defibrillator
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart FR3
In Commercial Distribution

  • 00884838049987 ()
861388

  • Rechargeable professional automated external defibrillator
HeartStart Infant/Child SMART Pads Cartridge
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Heartstart Infant Child Smart Pads Cart.
Not in Commercial Distribution

  • 00884838023758 ()
M5072A

  • External defibrillation electrode, paediatric, single-use
HeartStart Adult SMART Pads Cartridge
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Heartstart Adult Smart Pads Cartridge
In Commercial Distribution

  • 00884838023741 ()
M5071A

  • External defibrillation electrode, adult, single-use
HeartStart Infant/Child SMART Pads Cartridge
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Heartstart Infant Child Smart Pads Cart.
In Commercial Distribution

  • 00884838127784 ()
M5072A

  • External defibrillation electrode, paediatric, single-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
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.
6260
In Commercial Distribution

  • 00301936260019 ()
81914672

  • Glucose monitoring system IVD, home-use
Blood glucose test strips. Sold in a carton of 15 test strips.
ASCENSIA DIABETES CARE US INC.
7550
In Commercial Distribution

  • 40301937550155 ()
  • 00301937550157 ()
  • 10301937550154 ()
  • 00301937550065 ()
90001174

  • Glucose monitoring system IVD, home-use
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
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7311
In Commercial Distribution

  • 40301939736502 ()
  • 00301937311505 ()
  • 10301937311502 ()
  • 40301937311503 ()
  • 0193-7311-50 ()
  • 00301937311017 ()
  • 40301935540042 ()
83624710

  • Glucose monitoring system IVD, home-use
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