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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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BioFlo - H965103028050

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

BioFlo - H965103028030

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

BioFlo - H965103028010

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

Exodus - H965101510

Array Multipurpose Drainage Catheter 10F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10151
In Commercial Distribution

  • H965101511 ()
  • H965101510 ()
  • 15051684022507 ()

  • Outer Diameter: 3.4 Millimeter
  • Length: 25 Centimeter
  • Catheter Gauge: 10 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965101430

Array Multipurpose Drainage Catheter 8F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10143
In Commercial Distribution

  • H965101431 ()
  • H965101430 ()
  • 15051684022491 ()

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


  • Closed-wound drain, non-bioabsorbable

BioFlo - H965750210

BioFlo PICC with Endexo and PASV Valve Technology - 6F x 55cm Triple Lumen Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75021
In Commercial Distribution

  • H965750211 ()
  • H965750210 ()
  • 15051684026574 ()

  • Needle Gauge: 21 Gauge
  • Pressure: 325 Pound per Square Inch
  • Length: 55 Centimeter
  • Outer Diameter: 2.2 Millimeter
  • Catheter Gauge: 6 French


  • Peripherally-inserted central venous catheter

BioFlo - H965750190

BioFlo PICC with Endexo and PASV Valve Technology - 5F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75019
In Commercial Distribution

  • H965750191 ()
  • H965750190 ()
  • 15051684026550 ()

  • Catheter Gauge: 5 French
  • Outer Diameter: 1.75 Millimeter
  • Length: 55 Centimeter
  • Needle Gauge: 21 Gauge
  • Pressure: 325 Pound per Square Inch


  • Peripherally-inserted central venous catheter

BioFlo - H965750170

BioFlo PICC with Endexo and PASV Valve Technology - 4F x 55cm Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75017
In Commercial Distribution

  • H965750171 ()
  • H965750170 ()
  • 15051684026536 ()

  • Catheter Gauge: 4 French
  • Length: 55 Centimeter
  • Outer Diameter: 1.4 Millimeter
  • Needle Gauge: 21 Gauge
  • Pressure: 325 Pound per Square Inch


  • Peripherally-inserted central venous catheter

BioFlo - H965750150

BioFlo PICC with Endexo Technology - 6F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75015
In Commercial Distribution

  • H965750151 ()
  • H965750150 ()
  • 15051684026642 ()

  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.95 Millimeter
  • Length: 55 Centimeter
  • Pressure: 325 Pound per Square Inch
  • Catheter Gauge: 6 French


  • Peripherally-inserted central venous catheter

BioFlo - H965750130

BioFlo PICC with Endexo Technology - 5F x 55 cm Catheter Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.
75013
In Commercial Distribution

  • H965750131 ()
  • H965750130 ()
  • 15051684026611 ()

  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.7 Millimeter
  • Pressure: 325 Pound per Square Inch
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter
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