NxStage Medical, Inc.

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Description

14 dispositivos en la base de datos

  • Modelo / Serial
    Software version 4.9 and 4.10
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    NxStage System One S Cycler -High Permeability Hemodialysis System || Model no. NX1000-4
  • Modelo / Serial
    Software versions 4.9 and 4.10
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
  • Descripción del producto
    NxStage System One S Cycler (High Permeability Hemodialysis System) || Model no. NX1000-5-A
  • Modelo / Serial
    Lot code: 40179074
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • Descripción del producto
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-407 || Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 105, Glucose (mg/dL) 100 || Batch Size (liters) 50
  • Modelo / Serial
    Lot code: 40179126 40179125 40179108 40179036 40179035 31279119 3057923 3057907 3047927
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • Descripción del producto
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-307 || Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 105, Glucose (mg/dL) 100 || Batch Size (liters) 50 || 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.
  • Modelo / Serial
    Lot codes: 31279092 3047917 3047916
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • Descripción del producto
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-306 || Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, || Chloride 101, Glucose (mg/dL) 100 || Batch Size (liters) 50 || 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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Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    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
  • Dirección del fabricante
    NxStage Medical, Inc., 439 S Union St Fl 5th, Lawrence MA 01843-2837
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    NxStage Medical, Inc., 439 South Union Street, 5th Floor, Lawrence MA 01843-2800
  • Source
    USFDA