BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AP 720S™ Semi-Automated Processor

    DI: 00813382010211 · Model: 93602 · Minaris Medical America, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AP 720S™ Semi-Automated Processor
    Primary DI
    00813382010211
    Version / Model
    93602
    Catalog Number
    93602
    Company Name
    Minaris Medical America, Inc.
    Labeler DUNS
    102113867
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-08
    Public Version
    4
    Public Version Date
    2022-04-11
    Public Version Status
    Update
    Public Device Record Key
    991fc047-bbed-42a2-94a9-34b81d51b725

    Device Description

    AP 720S™ Semi-Automated Processor

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DHB System, test, radioallergosorbent (rast) immunological

    GMDN Terms

    Code Name
    56702 Chemiluminescent immunoassay analyser IVD, semi-automated

    Identifiers

    Type ID
    Primary 00813382010211

    Customer Contacts

    Phone
    +1(650)961-5501 ext. 686
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K112910 000