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510(k) Data Aggregation

    K Number
    K250445
    Device Name
    Fast Warm - NX
    Manufacturer
    FUJIFILM Irvine Scientific
    Date Cleared
    2025-09-12

    (210 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K190152
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fast Warm - NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.

    Device Description

    Fast Warm – NX is a dual-buffered solution (HEPES & MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) dextran serum supplement (DSS), and 1.0M trehalose. DSS is a protein supplement consisting of 50 mg/mL human serum albumin (HSA) and 20 mg/mL dextran. DSS is used at 20% (v/v) in Fast Warm – NX for a final concentration of 10 mg/mL HSA and 4 mg/mL dextran. The product is supplied as a ready to use liquid in two (2) different configurations, a kit containing multiple vials of either two (2) x 20mL or six (6) x 2mL. The medium can be used for up to 14 days after bottle opening.

    AI/ML Overview

    N/A

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