NaCl Fill/Syringe


Product Overview

NaCl Fill/Syringe
NA - 0295005000


Device Description

An assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., a prefilled syringe, one-way valves, and a side ported noncoring needle and/or slit catheter). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Total Volume: 3.0 Milliliter
    • Total Volume: 3.0 Milliliter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LXC

    Device Name: Monitor, Pressure, Intracompartmental

    Device Class: U

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: 1

    Implant Flag: N

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 34546540892851

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04546540892850

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: pack


    Device Id: 04546540892850

    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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