elabeling.terumobct.com


Product Overview

elabeling.terumobct.com
IMUGARD - 41950


Device Description

A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 30.00
    • 0.00
  • Special Storage Condition, Specify
    • Keep Dry (box and set level)
  • Special Storage Condition, Specify
    • Protect from Sun (set level)
  • Special Storage Condition, Specify
    • Fragile (box level)

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KSR

    Device Name: Container, Empty, For Collection & Processing Of Blood & Blood Components

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HE

    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: 864.9100

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 05020583419506

    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: 35020583419507

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 05020583419506

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


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