SYSTEM ATLGIQE AUTOLOG AUTOTRANS EVAL


Product Overview

SYSTEM ATLGIQE AUTOLOG AUTOTRANS EVAL
autoLog IQ™ - ATLGIQE


Device Description

An electrically-powered device intended to be used in conjunction with a collection of appropriate containers and tubing (not included) to produce pressure for the collection of blood from a patient and the subsequent processing (filter/wash) of the blood components (e.g., red or white blood cells, platelets) as part of an autotransfusion procedure. It typically incorporates a peristaltic and aspiration (suction) pump. This is a reusable device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store the device in a cool, dry, and well-ventilated area.
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 101.00
    • 59.50
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CAC

    Device Name: Apparatus, Autotransfusion

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    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: 868.5830

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 00763000057480

    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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