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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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Cardiva VASCADE 5F VCS - M729700500DX0

The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen

BioFlo - H965PKMR61072272S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61072272S
In Commercial Distribution

  • H965PKMR61072272S1 ()
  • H965PKMR61072272S0 ()

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


  • Peripherally-inserted central venous catheter

Xcela - H965PKMR61067721S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61067721S
In Commercial Distribution

  • H965PKMR61067721S1 ()
  • H965PKMR61067721S0 ()

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


  • Peripherally-inserted central venous catheter

BioFlo - H965PKMR61013791S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61013791S
In Commercial Distribution

  • H965PKMR61013791S1 ()
  • H965PKMR61013791S0 ()

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


  • Peripherally-inserted central venous catheter

Xcela - H965PKMR61010899S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61010899S
In Commercial Distribution

  • H965PKMR61010899S1 ()
  • H965PKMR61010899S0 ()

  • Catheter Gauge: 5 French
  • Length: 45 Centimeter
  • Dual


  • Peripherally-inserted central venous catheter

BioFlo - H965PKMR4024873S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR4024873S
In Commercial Distribution

  • H965PKMR4024873S1 ()
  • H965PKMR4024873S0 ()

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


  • Peripherally-inserted central venous catheter

BioFlo - H965PKMR22235S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR22235S
In Commercial Distribution

  • H965PKMR22235S1 ()
  • H965PKMR22235S0 ()

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


  • Peripherally-inserted central venous catheter

Xcela - H965PKMR22233S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR22233S
In Commercial Distribution

  • H965PKMR22233S1 ()
  • H965PKMR22233S0 ()

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


  • Peripherally-inserted central venous catheter

BioFlo - H965PKMR215704S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR215704S
In Commercial Distribution

  • H965PKMR215704S1 ()
  • H965PKMR215704S0 ()

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


  • Peripherally-inserted central venous catheter

BioFlo - H965PKMR215701S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR215701S
In Commercial Distribution

  • H965PKMR215701S1 ()
  • H965PKMR215701S0 ()

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


  • Peripherally-inserted central venous catheter
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