Revaclear 300 dialyzer is indicated for the treatment of chronic or acute renal failure.


Product Overview

Revaclear 300 dialyzer is indicated for the treatment of chronic or acute renal failure.
Revaclear - Revaclear 300


Device Description

A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • N/A

  • Device Sizes

  • Area/Surface Area: 1.4 Square meter
    • Area/Surface Area: 1.4 Square meter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KDI

    Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 876.5860

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 50085412908439

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00085412908434

    Package Quantity: 24

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 00085412908434

    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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