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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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15.5Fx32cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-805
In Commercial Distribution

  • H965103028051 ()
  • H965103028050 ()
  • 15051684025423 ()

  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter
  • Length: 32 Centimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable
15.5Fx28cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-804
In Commercial Distribution

  • H965103028041 ()
  • H965103028040 ()
  • 15051684025416 ()

  • Needle Gauge: 18 Gauge
  • Length: 28 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter


  • Double-lumen haemodialysis catheter, implantable
15.5Fx24cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-803
In Commercial Distribution

  • H965103028031 ()
  • H965103028030 ()
  • 15051684025409 ()

  • Outer Diameter: 5.2 Millimeter
  • Needle Gauge: 18 Gauge
  • Length: 24 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
15.5Fx22cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-802
In Commercial Distribution

  • H965103028021 ()
  • H965103028020 ()
  • 15051684025393 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 15.5 French
  • Outer Diameter: 5.2 Millimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable
15.5Fx20cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit
NAVILYST MEDICAL, INC.
02-801
In Commercial Distribution

  • H965103028011 ()
  • H965103028010 ()
  • 15051684025386 ()

  • Needle Gauge: 18 Gauge
  • Length: 20 Centimeter
  • Outer Diameter: 5.2 Millimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM61014921S
In Commercial Distribution

  • H965PKM61014921S1 ()
  • H956PKM61014921S0 ()

  • Single
  • Catheter Gauge: 4 French
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM033511S
In Commercial Distribution

  • H965PKM033511S1 ()
  • H954PKM033511S0 ()

  • Dual
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
60M701104
In Commercial Distribution

  • H96560M7011041 ()
  • H96560M7011040 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 6 French
  • Triple Lumen


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
60M701103
In Commercial Distribution

  • H96560M7011031 ()
  • H96560M7011030 ()

  • Length: 55 Centimeter
  • Triple Lumen
  • Catheter Gauge: 6 French


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
60M701102
In Commercial Distribution

  • H96560M7011021 ()
  • H96560M7011020 ()

  • Catheter Gauge: 5 French
  • Dual Lumen
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter
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