BEQ-HMO 71000 Quadrox i Adult with integral filter VHK 71000 Venous Reservoir - uncoated BEQ-RF32 RotaFlow BMU Cell Ven. 1/2 Prebypass filter w/o Vent 1/2 - 1/2 Bacteria filter Gas Filter


Product Overview

BEQ
Open Heart Pack - BEQ-TOP 29400


Device Description

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

  • Ethylene Oxide
    • Ethylene Oxide


    Product Codes

    Code: DWE

    Device Name: Tubing, Pump, 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: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.4390

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00607567208650

    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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