BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Procleix

    DI: 15420045500709 · Model: Procleix System Fluid Preservative · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Procleix
    Primary DI
    15420045500709
    Version / Model
    Procleix System Fluid Preservative
    Catalog Number
    301175
    Company Name
    Hologic, Inc.
    Labeler DUNS
    050579217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-08-06
    Public Version
    4
    Public Version Date
    2020-01-01
    Public Version Status
    Update
    Public Device Record Key
    95bbe532-bcb2-4a13-ba95-180890b064e5

    Device Description

    Not required for BLA products.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MZA TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN

    GMDN Terms

    Code Name
    48216 HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 15420045500709