BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Procedure Products Bag Spigot

    DI: B16047101 · Model: 4710 · PROCEDURE PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Procedure Products Bag Spigot
    Primary DI
    B16047101
    Version / Model
    4710
    Company Name
    PROCEDURE PRODUCTS, INC.
    Labeler DUNS
    151507563
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-12
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    74e70bef-337c-4d9a-88b2-02e74cf12bb4

    Device Description

    SPIGOT, NON-VENTED BAG 6" TUBE

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPE Container, I.V.

    GMDN Terms

    Code Name
    60540 Intravenous fluid bag spike

    Identifiers

    Type ID
    Primary B16047101

    Premarket Submissions

    Submission Number Supplement Number
    K910673 000