BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PlasmaCon L2

    DI: 10859394006085 · Model: 32-201 · R 2 DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    PlasmaCon L2
    Primary DI
    10859394006085
    Version / Model
    32-201
    Catalog Number
    32-201
    Company Name
    R 2 DIAGNOSTICS, INC.
    Labeler DUNS
    956610125
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-11-15
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    f812578d-a4b7-4e2b-b7f2-e9731fec1ef5

    Device Description

    Abnormal Control L-2 10 x 1 ml

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GGC Control, Plasma, Abnormal
    GIZ Plasma, Control, Normal

    GMDN Terms

    Code Name
    30590 Multiple coagulation factor IVD, control

    Identifiers

    Type ID
    Primary 10859394006085
    Unit of Use 00859394006088

    Premarket Submissions

    Submission Number Supplement Number
    K062306 000