HMO 70000 (BO coated) Quadrox i Adult BO-VHK 71000 Venous Reservoir BO-RF32 RotaFlow CDI Sat Cell 1/2" System 100 Prebypass filter w/o Vent Porous Media 3/8x1/2 Gas Filter

Product Overview

HMO 70000 (BO coated) Quadrox i Adult BO
Open Heart without Plegiox - BO-TOP 14605

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

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 10.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Ethylene Oxide
    • Ethylene Oxide

    Product Codes

    Code: DWF

    Device Name: Catheter, Cannula And Tubing, Vascular, 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: 870.4210

    Third Party Flag: Y

    Medical Specialty: CV

    Device Identifiers

    Device Id: 00607567206311

    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

    Educational Resources