BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MPS 3 ND Delivery Set w/o AA w/305cm Line (16C)

    DI: 00634624530362 · Model: 5ND3100 · QUEST MEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MPS 3 ND Delivery Set w/o AA w/305cm Line (16C)
    Primary DI
    00634624530362
    Version / Model
    5ND3100
    Company Name
    QUEST MEDICAL INC
    Labeler DUNS
    041810693
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-05
    Public Version
    2
    Public Version Date
    2021-10-19
    Public Version Status
    Update
    Public Device Record Key
    80777416-c1be-45fd-be17-f3f55f4632a1

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

    GMDN Terms

    Code Name
    16163 Cardioplegia solution administration kit

    Identifiers

    Type ID
    Package 20634624530366
    Primary 00634624530362

    Premarket Submissions

    Submission Number Supplement Number
    K201984 000