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510(k) Data Aggregation

    K Number
    K140571
    Device Name
    NXSTAGE PUREFLOW SL
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2014-05-15

    (70 days)

    Product Code
    FKR
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage PureFlow SL module is an optional accessory to the NxStage System One™ that prepares dialysate for use during hemodialysis, as prescribed by the physician.
    Device Description
    The NxStage PureFlow SL module is an optional accessory to the NxStage System One used to prepare water for hemodialysis that meets ANSI/AAMI/ISO 13959:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PureFlow SL consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.
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    K Number
    K111174
    Device Name
    NXSTAGE PUREFLOW SL
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2011-09-19

    (145 days)

    Product Code
    FKR, DEV
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
    Device Description
    The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis per ANSI/AAMI/ISO 13959:2009 and ANSI/AAMI/ISO 26722:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.
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    K Number
    K080919
    Device Name
    NXSTAGE PUREFLOW SL
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2008-10-15

    (197 days)

    Product Code
    FKR
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
    Device Description
    The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.
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    K Number
    K060296
    Device Name
    NXSTAGE DIALYSATE PREPARATION MODULE
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2006-03-31

    (53 days)

    Product Code
    FKR, FIP
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
    Device Description
    The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that pre-treats and purifies water that mixes with concentrate to produce dialysate meeting the requirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis treatments.
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    K Number
    K043436
    Device Name
    NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2005-03-17

    (94 days)

    Product Code
    FKR
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
    Device Description
    Device Booonproniment and optional accessory to the NxStage System The NAGtage Dialyone in that mixes with concentrate to produce One that pro treats crequirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis therapies.
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