BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sweat Control Level 1, 2, & 3 Set 9x3mL

    DI: 00896863002028 · Model: 1190-01 · QUANTIMETRIX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sweat Control Level 1, 2, & 3 Set 9x3mL
    Primary DI
    00896863002028
    Version / Model
    1190-01
    Catalog Number
    1190-01
    Company Name
    QUANTIMETRIX CORPORATION
    Labeler DUNS
    010717890
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-26
    Public Version
    1
    Public Version Date
    2018-10-29
    Public Version Status
    New
    Public Device Record Key
    fe4abe4c-64c8-46dc-9242-581dfd45bdd2

    Device Description

    The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures and to validate the analysis of Chloride, Potassium, and Sodium by confirmatory methods used to quantitate patient samples. They are liquid, ready-to-use, requiring no reconstitution or dilution. They are supplied in three levels, nine vials per box, 3x3mL each level. They are prepared in an aqueous simulated human sweat matrix to which preservatives have been added.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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

    Product Codes

    Code Name
    JJR Electrolyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    52868 Multiple electrolyte IVD, control

    Identifiers

    Type ID
    Primary 00896863002028
    Secondary M0511190011

    Customer Contacts

    Phone
    (310) 536-0006
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K943925 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    18 – 25 Degrees Celsius