BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    xMAP® Sheath Fluid PLUS

    DI: 00840487101803 · Model: 40-50035 · LUMINEX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    xMAP® Sheath Fluid PLUS
    Primary DI
    00840487101803
    Version / Model
    40-50035
    Company Name
    LUMINEX CORPORATION
    Labeler DUNS
    965476641
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-04
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    0eb0eb94-65e3-4ca6-b2da-88048f4929d5

    Device Description

    Sheath Fluid PLUS is the delivery medium of the sample to the optics component.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    NSU Instrumentation for clinical multiplex test systems

    GMDN Terms

    Code Name
    56727 Multiplex analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 00840487101803

    Customer Contacts

    Phone
    +1(512)381-4397
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K073506 000
    K121399 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius