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    K Number
    K083686
    Device Name
    BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
    Manufacturer
    ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2009-07-02

    (202 days)

    Product Code
    FMF,FMI
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.

    Device Description

    BAIXIN Disposable Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.

    AI/ML Overview

    The provided text describes the acceptance criteria and the summary of testing for the BAIXIN™ Disposable Syringe. It focuses on the device's adherence to ISO 7886-1:1993, a consensus standard for sterile hypodermic syringes.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Testing ItemsAcceptance Criteria (Code Requirement)Reported Device Performance
    Syringe Column Sealing (Positive Pressure)300 Kpa Positive Pressure - No leakageMeets criteria (implied by "Data supporting conformance")
    Syringe Column Sealing (Negative Pressure)88 Kpa Negative Pressure - No leakageMeets criteria (implied by "Data supporting conformance")
    Volume± 4%Meets criteria (implied by "Data supporting conformance")
    Tip Sealing PropertyNo LeakageMeets criteria (implied by "Data supporting conformance")
    Indicating Ruler - 0 level lineWithin 1/4 rangeMeets criteria (implied by "Data supporting conformance")
    Tip SizeNo separation at 25N (This seems to be a strength/connection test for the tip)Meets criteria (implied by "Data supporting conformance")
    Draw StrengthNot specified in the table's "Code Requirement" column.Not explicitly reported numerically, but implied conformance.
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