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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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ENVI - H965355010

NVI SHEATH 6F X 20CM
NAVILYST MEDICAL, INC.
35-501
In Commercial Distribution

  • H965355010 ()
  • H965355011 ()
  • 15051684023542 ()

  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 20 Centimeter
  • NA


  • Vascular catheter introduction set, nonimplantable

Exodus - H965100020

8F x 25cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10002
Not in Commercial Distribution

  • H965100021 ()
  • H965100020 ()

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


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100010

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

BioFlo - H956PKM61014921S0

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

BioFlo - H954PKM033511S0

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

AngioDynamics - H965457860

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45786
In Commercial Distribution

  • H965457861 ()
  • H965457860 ()

  • Outer Diameter: 1.73 Millimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457850

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45785
In Commercial Distribution

  • H965457851 ()
  • H965457850 ()

  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457840

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45784
In Commercial Distribution

  • H965457841 ()
  • H965457840 ()

  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457830

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45783
In Commercial Distribution

  • H965457831 ()
  • H965457830 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457820

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45782
In Commercial Distribution

  • H965457821 ()
  • H965457820 ()

  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.73 Millimeter
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable
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