BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    EDGE BIOLOGICALS INC

    DI: B645SB50DEF1 · Model: SB50DEF · EDGE BIOLOGICALS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    EDGE BIOLOGICALS INC
    Primary DI
    B645SB50DEF1
    Version / Model
    SB50DEF
    Company Name
    EDGE BIOLOGICALS, INC.
    Labeler DUNS
    047927827
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    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
    0042abcc-1209-41c2-a9a9-d82b24bcbb30
    Distribution End Date
    2025-04-21

    Device Description

    SHEEP BLOOD DEFIB 50ML

    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
    62819 Sheep blood supplement IVD

    Identifiers

    Type ID
    Primary B645SB50DEF1