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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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15.5Fx28cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Kit
NAVILYST MEDICAL, INC.
02-904
In Commercial Distribution

  • H965103029041 ()
  • H965103029040 ()
  • 15051684025881 ()

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


  • Double-lumen haemodialysis catheter, implantable
15.5Fx24cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Kit
NAVILYST MEDICAL, INC.
02-903
In Commercial Distribution

  • H965103029031 ()
  • H965103029030 ()
  • 15051684025775 ()

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


  • Double-lumen haemodialysis catheter, implantable
15.5Fx32cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
02-820
In Commercial Distribution

  • H965103028201 ()
  • H965103028200 ()
  • 15051684025614 ()

  • Length: 32 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 VascPak Kit
NAVILYST MEDICAL, INC.
02-818
In Commercial Distribution

  • H965103028181 ()
  • H965103028180 ()
  • 15051684025591 ()

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


  • Double-lumen haemodialysis catheter, implantable
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
15.5Fx22cm 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
10F x 35cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10032
Not in Commercial Distribution

  • H965100321 ()
  • H965100320 ()

  • Length: 35 Centimeter
  • Catheter Gauge: 10 French
  • Outer Diameter: 3.4 Millimeter


  • Closed-wound drain, non-bioabsorbable
8F x 25cm Tight Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10003
Not in Commercial Distribution

  • H965100031 ()
  • H965100030 ()

  • Length: 25 Centimeter
  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter


  • Closed-wound drain, non-bioabsorbable
8F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10001
Not in Commercial Distribution

  • H965100011 ()
  • H965100010 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 20 Centimeter


  • Closed-wound drain, non-bioabsorbable
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
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