CareFusion SmartSite VialShield 13mm Closed Vial Access Device


Product Overview

CareFusion SmartSite VialShield 13mm Closed Vial Access Device
SmartSite - MV0513


Device Description

A device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing with a spike that attaches to or replaces the container lid, plus a Luer connection and sealed expansion chamber (e.g., balloon), allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Lumen/Inner Diameter: 13 Millimeter
    • Lumen/Inner Diameter: 13 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LHI

    Device Name: Set, I.V. Fluid Transfer

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 880.5440

    Third Party Flag: Y

    Medical Specialty: HO


    Device Identifiers

    Device Id: 50885403228108

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403228100

    Package Quantity: 50

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 10885403228100

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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