BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AngelMed Guardian EXD Model EXD-001

    DI: 00850012625032 · Model: 0203-2100-002-C4#P16 · Angel Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AngelMed Guardian EXD Model EXD-001
    Primary DI
    00850012625032
    Version / Model
    0203-2100-002-C4#P16
    Catalog Number
    0203-2100-002-C4#P16
    Company Name
    Angel Medical Systems, Inc.
    Labeler DUNS
    171391779
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-25
    Public Version
    1
    Public Version Date
    2021-03-05
    Public Version Status
    New
    Public Device Record Key
    053f8ec7-3865-43bc-9e3a-d195a3692cbd

    Device Description

    EXD-001 Kit (Latin-American Spanish)

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QBI Acute coronary syndrome event detector

    GMDN Terms

    Code Name
    47805 Implantable cardiac monitor programmer/transmitter/alarm

    Identifiers

    Type ID
    Primary 00850012625032

    Premarket Submissions

    Submission Number Supplement Number
    P150009 000