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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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NAMIC Acceler-8 Angiographic 8 ml Control Syringe with Rotating Adaptor with Reservoir
NAVILYST MEDICAL, INC.
80084007
In Commercial Distribution

  • H965800840071 ()
  • H965800840070 ()

  • 8 ml


  • Stopcock
NAMIC Acceler-8 Angiographic 8 ml Control Syringe with Male Luer Lock with Reservoir
NAVILYST MEDICAL, INC.
80084003
In Commercial Distribution

  • H965800840031 ()
  • H965800840030 ()

  • 8 ml


  • Stopcock
NAMIC Saver-7 Angiographic 7 ml Control Syringe with Rotating Adaptor without Reservoir
NAVILYST MEDICAL, INC.
80083017
In Commercial Distribution

  • H965800830171 ()
  • H965800830170 ()

  • 7 ml


  • Stopcock
BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit.
NAVILYST MEDICAL, INC.
75-063
In Commercial Distribution

  • H965750630 ()
  • H965750631 ()
  • 15051684026482 ()

  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.73 Millimeter
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
  • Pressure: 214 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo PICC with ENDEXO and PASV Valve Technology (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit.
NAVILYST MEDICAL, INC.
75-061
In Commercial Distribution

  • H965750610 ()
  • H965750611 ()
  • 15051684026468 ()

  • Outer Diameter: 1.4 Millimeter
  • Needle Gauge: 21 Gauge
  • Pressure: 220 Pound per Square Inch
  • Catheter Gauge: 4 French
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter
BioFlo PICC with ENDEXO Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
75-060
In Commercial Distribution

  • H965750600 ()
  • H965750601 ()
  • 15051684026864 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 6 French
  • Outer Diameter: 2.11 Millimeter
  • Needle Gauge: 21 Gauge
  • Pressure: 268 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo PICC with Endexo and PASV Valve Technology - 5F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)
NAVILYST MEDICAL, INC.
75038
In Commercial Distribution

  • H965750385 ()
  • H965750380 ()
  • 15051684026352 ()

  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
  • Pressure: 325 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo PICC with Endexo and PASV Valve Technology - 5F x 55cm Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)
NAVILYST MEDICAL, INC.
75037
In Commercial Distribution

  • H965750375 ()
  • H965750370 ()
  • 15051684026598 ()

  • Needle Gauge: 21 Gauge
  • Length: 55 Centimeter
  • Pressure: 325 Pound per Square Inch
  • Outer Diameter: 1.68 Millimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter
BioFlo PICC with Endexo Technology - 6F x 55cm Triple Lumen Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)
NAVILYST MEDICAL, INC.
75035
In Commercial Distribution

  • H965750355 ()
  • H965750350 ()
  • 15051684026758 ()

  • Length: 55 Centimeter
  • Outer Diameter: 2.11 Millimeter
  • Catheter Gauge: 6 French
  • Needle Gauge: 21 Gauge
  • Pressure: 325 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo PICC with Endexo Technology - 5F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)
NAVILYST MEDICAL, INC.
75033
In Commercial Distribution

  • H965750335 ()
  • H965750330 ()
  • 15051684026727 ()

  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
  • Pressure: 325 Pound per Square Inch
  • Needle Gauge: 21 Gauge


  • Peripherally-inserted central venous catheter
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