BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    EDGE BIOLOGICALS INC

    DI: B645T0453 · Model: T0453 · EDGE BIOLOGICALS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    EDGE BIOLOGICALS INC
    Primary DI
    B645T0453
    Version / Model
    T0453
    Company Name
    EDGE BIOLOGICALS, INC.
    Labeler DUNS
    047927827
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2025-04-21
    Public Version
    1
    Public Version Date
    2025-04-29
    Public Version Status
    New
    Public Device Record Key
    ea625fe0-f547-41ff-abe6-77671a4655a5
    Distribution End Date
    2025-04-21

    Device Description

    PHOSPHATE BUFFER SALINE 3ML

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    PPM General Purpose Reagent

    GMDN Terms

    Code Name
    42651 Buffered isotonic saline reagent IVD

    Identifiers

    Type ID
    Unit of Use B645T04531
    Primary B645T0453