Full Perforation Flat Silicone Wound Drain


Product Overview

Full Perforation Flat Silicone Wound Drain
NA - 0212013000


Device Description

An assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is typically actuated by a central vacuum system. A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Diameter: 10.0 Millimeter
    • Diameter: 10.0 Millimeter


    Device Sterilization

    Device Sterile: True

    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: 34546540184819

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04546540184818

    Package Quantity: 10

    Package Discontinue Date: 4/1/2019 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: pack


    Device Id: 04546540184818

    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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