BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Osmolarity Normal Control Solutions

    DI: 00853539002041 · Model: 100012 · Tearlab Corporation
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    500

    Basic Information

    Brand Name
    Osmolarity Normal Control Solutions
    Primary DI
    00853539002041
    Version / Model
    100012
    Company Name
    Tearlab Corporation
    Labeler DUNS
    155813749
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    500
    Record Status
    Published
    Publish Date
    2024-01-05
    Public Version
    2
    Public Version Date
    2024-01-18
    Public Version Status
    Update
    Public Device Record Key
    667cca4b-a42d-4bf8-b25f-3dd5e3b37c04

    Device Characteristics

    Single Use
    Yes
    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
    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

    GMDN Terms

    Code Name
    52886 Osmolality IVD, control

    Identifiers

    Type ID
    Unit of Use 10853539002048
    Primary 00853539002041