BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ESR-Chex Plus

    DI: 00844509002185 · Model: 240408 · STRECK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ESR-Chex Plus
    Primary DI
    00844509002185
    Version / Model
    240408
    Catalog Number
    240408
    Company Name
    STRECK, INC.
    Labeler DUNS
    072915986
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    1ac99ff9-e555-46da-a21a-01bb1777be2a

    Device Description

    A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 6 vials each of level 1 & 2.

    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
    Yes
    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
    JPH Test, Erythrocyte Sedimentation Rate

    GMDN Terms

    Code Name
    55972 Erythrocyte sedimentation rate (ESR) IVD, control

    Identifiers

    Type ID
    Primary 00844509002185

    Customer Contacts

    Phone
    1-800-228-6090
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 3.0 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 10 Degrees Celsius