Cardiovascular Procedure Kit

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Corporation, 125 Blue Ball Road, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

20 devices with a similar name

Learn more about the data here

  • Model / Serial
    Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of MO and FL.
  • Product Description
    Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. || For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
  • Manufacturer
  • Model / Serial
    Lot Number: TE06
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Product Description
    Terumo Custom Cardiovascular Procedure Kit Tubing Pack || P/N: 66041-1 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.
  • Manufacturer
  • Model / Serial
    Lot Numbers: TD02,TD02A, TD23, TD23A
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Product Description
    Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak || P/N: 73124 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
  • Manufacturer
  • 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
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