Acute Dual Lumen Catheter Tray,Pre-Curved with IC* Components,11.5 Fr/Ch (3.8 mm) x 13.5 cm


Product Overview

Acute Dual Lumen Catheter Tray,Pre
MAHURKAR - 8888115133


Device Description

A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 59.00

  • Device Sizes

  • Catheter Gauge: 11.5 French
  • Length, 13.5, CM; French Catheter, 11.5, Guage;
  • Length: 13.5 Centimeter
    • Catheter Gauge: 11.5 French
    • Length, 13.5, CM; French Catheter, 11.5, Guage;
    • Length: 13.5 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FOZ

    Device Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    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: 880.5200

    Third Party Flag: Y

    Medical Specialty: HO


    Device Identifiers

    Device Id: 20884521005409

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521005402

    Package Quantity: 5

    Package Discontinue Date: 7/31/2020 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: PACK_OR_INNER_PACK


    Device Id: 10884521005402

    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


    Device Id: 10884521519428

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 20884521005409

    Package Quantity: 4

    Package Discontinue Date: 7/31/2020 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: CASE


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