BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Stat Profile

    DI: 00385480574587 · Model: Prime Plus · NOVA BIOMEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Stat Profile
    Primary DI
    00385480574587
    Version / Model
    Prime Plus
    Catalog Number
    57458
    Company Name
    NOVA BIOMEDICAL CORPORATION
    Labeler DUNS
    070617139
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    1
    Public Version Date
    2022-12-16
    Public Version Status
    New
    Public Device Record Key
    99aa2e07-bbf4-40e9-a2fd-d574f47c7481

    Device Description

    Calibrator Flush Fixture

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    CGA GLUCOSE OXIDASE, GLUCOSE
    CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
    GGZ OXYHEMOGLOBIN

    GMDN Terms

    Code Name
    56681 Single-channel clinical chemistry analyser IVD, point-of-care

    Identifiers

    Type ID
    Primary 00385480574587

    Customer Contacts

    Phone
    +1(800)545-6682
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius