NxStage Medical, Inc.

14 devices in the database

  • Model / Serial
    SAK-301- Lot # 70879245, Exp Date 7/11/2019 SAK-302- Lot # 71079056, Exp Date 7/30/2019 SAK-303- Lot #'s 70879181 & 70879224,  SAK-304- Lot #'s 70779236, 70879045, 70879105, 70879220 & 70979066, Exp Date 7/8/2019 SAK-306- Lot # 70979110, Exp Date 7/24/2019 SAK-307- Lot #'s 70879187 & 71079144, Exp Date 8/27/2019 SAK-402- Lot # 70879235, Exp Date 7/11/2019 SAK-405- Lot #'s 70779202 & 70879233, Exp Date 7/9/2019 SAK-406- Lot #'s 70979253, Exp Date 7/29/2019 SAK-407- Lot #'s 70879236 , Exp Date 7/11/2019
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain
  • Product Description
    NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 || Hemodialysis systems and accessories
  • Model / Serial
    RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution
  • Product Description
    NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
  • Model / Serial
    F023444
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
  • Product Description
    NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case || The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
  • Model / Serial
    Lot Number: F113662
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of NY, TX, ID, AR, CA and AL
  • Product Description
    NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. || The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
  • Model / Serial
    Lot codes: 40279015 40179163 40179162 31279127 3067903 3057931 3057930 3047933 3047928
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • Product Description
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-301 || Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 100, Glucose (mg/dL) 100 || Batch Size (liters) 60 || The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
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4 manufacturers with a similar name

Learn more about the data here

  • 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 S Union St Fl 5th, Lawrence MA 01843-2837
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Address
    NxStage Medical, Inc., 439 South Union Street, 5th Floor, Lawrence MA 01843-2800
  • Source
    USFDA