BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Maintenance Solution Kit Large

    DI: 07333066000985 · Model: 10-9537-01 · Phadia AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Maintenance Solution Kit Large
    Primary DI
    07333066000985
    Version / Model
    10-9537-01
    Catalog Number
    10-9537-01
    Company Name
    Phadia AB
    Labeler DUNS
    354019424
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-31
    Public Version
    1
    Public Version Date
    2020-04-08
    Public Version Status
    New
    Public Device Record Key
    89cfcae5-c909-4f55-b1c8-bed161aa3240

    Device Description

    Contains eight ampules of Maintenance Concentrate for use with Phadia instruments.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    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
    JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

    GMDN Terms

    Code Name
    53961 Plasma protein IVD, reagent

    Identifiers

    Type ID
    Primary 07333066000985

    Customer Contacts

    Phone
    +469999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius