Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253462

    Validate with FDA (Live)

    Date Cleared
    2026-01-29

    (114 days)

    Product Code
    Regulation Number
    876.5820
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.

    Device Description

    The NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is composed of dry sodium bicarbonate. NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is available in a 7807 g presentation that yields 25.36 gallons (96 liters) of bicarbonate concentrate volume. The 7807 g NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is supplied in bag-style packaging.

    The NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is a non-sterile, single use Class II medical device composed of United States Pharmacopeia (USP) grade sodium bicarbonate.

    NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1