BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Quantum SuperPAC Adapter Tubing Set 3/8

    DI: 18051160303349 · Model: CGSP8-B2 · SPECTRUM MEDICAL SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Quantum SuperPAC Adapter Tubing Set 3/8
    Primary DI
    18051160303349
    Version / Model
    CGSP8-B2
    Company Name
    SPECTRUM MEDICAL SRL
    Labeler DUNS
    436188505
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-31
    Public Version
    1
    Public Version Date
    2026-04-08
    Public Version Status
    New
    Public Device Record Key
    8723fa1d-475c-4448-a717-3651554cc963

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

    GMDN Terms

    Code Name
    16163 Cardioplegia solution administration kit

    Identifiers

    Type ID
    Primary 18051160303349

    Premarket Submissions

    Submission Number Supplement Number
    K213540 000