Procedure Kit

  • Model / Serial
    Part Number: K09-05248AP. Lot Numbers: A348563, A360799, A365773, A370274, A372525, A377402, A382733, A388638, F392744.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.
  • Product Description
    Merit Custom Procedure Kit
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Merit Medical Systems, Inc, 1600 West Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA

135 devices with a similar name

Learn more about the data here

  • Model / Serial
    TAOS, TC03
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
  • Product Description
    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
  • Manufacturer
  • Model / Serial
    662143 735568 752561 767041 774364 775404 778816 783025 785629 794402 794411 735568
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL
  • Product Description
    Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. || The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ Leukocy1e Reduction Arterial Blood Filter for Exh¿acorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 ¿m in size from the perfu sate during exh¿acorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard ¿ Leukocyte Reduction Arterial Blood Filter can be included in Cardiovascular Procedure Kits (Convenience Kits). When the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters is included in the Kits, the intended use of the filter remains unaffected.
  • Manufacturer
  • Model / Serial
    Lot number 47303 exp 9/30/06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
  • Product Description
    TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach.
  • Manufacturer
  • Model / Serial
    Lot number 47303 exp 9/30/06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
  • Product Description
    TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using femoral approach.
  • Manufacturer
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