Prelude Short Sheath Introducer

  • Model / Serial
    Lot numbers: F651361 and F661593.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.
  • Product Description
    8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needle; and 0.018" X 40CM NT/PT Guide Wire; REF No.: PSS-8F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 Merit Pkwy, South Jordan UT 84095
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

22 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: H1041469, H1041473, H1036880, H1041464.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
  • Product Description
    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. || Produc Usage: || The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
  • Manufacturer
  • Model / Serial
  • Product Description
    Injections / Infusions / Transfusions / Dialysis
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Merit 7F Prelude Short Sheath Introducers
  • Manufacturer
  • Model / Serial
    Lot number V686326.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.
  • Product Description
    Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medical Systems, Inc., South Jordan, Utah 84095. || To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
  • Manufacturer
  • Model / Serial
    Lot number V681838.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.
  • Product Description
    Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-02894C, Merit Medical Systems, Inc., South Jordan, Utah 84095. || To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
  • Manufacturer
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