SYSTEM ACS500 AUTOCLAMP


Product Overview

SYSTEM ACS500 AUTOCLAMP
NA - ACS500


Device Description

A non-sterile, manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a reusable device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Atmospheric Limitation of 700 hPa to 1060 hPa
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 66.00
    • -40.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DWA

    Device Name: Control, Pump Speed, Cardiopulmonary Bypass

    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: 870.4380

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00613994258250

    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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