NxStage Medical, Inc.

One device in the database

  • Model / Serial
    Lot 1117911, Exp. 2013-09
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx || The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.

4 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
  • Manufacturer Address
    NxStage Medical, Inc., 439 South Union Street, 5th Floor, Lawrence MA 01843-2800
  • Source
    USFDA