BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Poly stat

    DI: 00855574005384 · Model: HCG25 · POLYMEDCO, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Poly stat
    Primary DI
    00855574005384
    Version / Model
    HCG25
    Company Name
    POLYMEDCO, INC.
    Labeler DUNS
    024798555
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    0e523c9b-5aa8-4e49-8c93-b1f43ca61d12

    Device Description

    HCG, Immunochromatographic Test

    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
    No
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

    GMDN Terms

    Code Name
    43740 Human chorionic gonadotropin alpha-subunit IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 00855574005384

    Premarket Submissions

    Submission Number Supplement Number
    K020439 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius