BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aero-Med

    DI: 10885380187902 · Model: CA38275 · AERO-MED, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Aero-Med
    Primary DI
    10885380187902
    Version / Model
    CA38275
    Catalog Number
    CA38275
    Company Name
    AERO-MED, LLC
    Labeler DUNS
    194550042
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-20
    Public Version
    1
    Public Version Date
    2026-03-02
    Public Version Status
    New
    Public Device Record Key
    28aba41a-2534-4af5-8f5b-236face22ae6

    Device Description

    Prostate Biopsy Kit for Cottage Health - PDL only

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OIB Blood and urine collection kit (excludes HIV testing)

    GMDN Terms

    Code Name
    44904 Blood/tissue storage/culture container

    Identifiers

    Type ID
    Package 50885380187900
    Primary 10885380187902