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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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
The Cardiva Catalyst III consists of a sterile disposable Catalyst III Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III is specifically designed for use with heparinized patients. The Cardiva Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst III is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
CARDIVA MEDICAL, INC.
600-580CP
In Commercial Distribution

  • M729600580CP2 ()
  • M729600580CP0 ()

  • Catheter Gauge: 6 French
  • Catheter Gauge: 7 French
  • Catheter Gauge: 5 French


  • Femoral artery compression system, single-use
The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
CARDIVA MEDICAL, INC.
500-580C
In Commercial Distribution

  • M729500580C2 ()
  • M729500580C0 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French
  • Catheter Gauge: 5 French


  • Femoral artery compression system, single-use
MynxGrip Vascular Closure Device (5F)
Access Closure, Inc.
MX5021
In Commercial Distribution

  • M465MX50210 ()
  • M465MX50211 ()

  • Catheter Gauge: 5 French
MX5021

  • Wound hydrogel dressing, non-antimicrobial
PICC Convenience Kit
NAVILYST MEDICAL, INC.
60M033561
In Commercial Distribution

  • H74960M0335610 ()
  • H74960M0335611 ()

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


  • Peripherally-inserted central venous catheter
Saline/Contrast Media Infusion Catheter, 5 Fr. with Integrated Stylet
UTAH MEDICAL PRODUCTS, INC.
Integrated Stylet
In Commercial Distribution

  • H671MIS50ST1 ()
  • H671MIS50ST0 ()

  • Catheter Gauge: 5 French
  • Length: 30 Centimeter
MIS-50ST

  • Intrauterine imaging medium catheter
Saline/Contrast Media Infusion Catheter, 5 Fr. with Peel-Away Introducer
UTAH MEDICAL PRODUCTS, INC.
Peel-Away Introducer
In Commercial Distribution

  • H671MIS50P1 ()
  • H671MIS50P0 ()

  • Catheter Gauge: 5 French
  • Length: 30 Centimeter
MIS-50P

  • Intrauterine imaging medium catheter
A Triple-Lumen Polyurethane Umbilical Catheter, 5 French
UTAH MEDICAL PRODUCTS, INC.
Triple-Lumen Polyurethane
In Commercial Distribution

  • H67143850051 ()
  • H67143850050 ()

  • Length: 37 Centimeter
  • Catheter Gauge: 5 French
4385005

  • Umbilical catheter
A Dual-Lumen Polyurethane Umbilical Catheter, 5 French
UTAH MEDICAL PRODUCTS, INC.
Dual-Lumen Polyurethane
In Commercial Distribution

  • H67142850051 ()
  • H67142850050 ()

  • Length: 37 Centimeter
  • Catheter Gauge: 5 French
4285005

  • Umbilical catheter
A Dual-Lumen Silicone Umbilical Catheter, 5 French
UTAH MEDICAL PRODUCTS, INC.
Dual-Lumen Silicone
In Commercial Distribution

  • H67142750051 ()
  • H67142750050 ()

  • Length: 34 Centimeter
  • Catheter Gauge: 5 French
4275005

  • Umbilical catheter
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