BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZELLESR-10

    DI: 00860011967712 · Model: 11.ZE10 · STERILE SAFEQUIP & CHEMICALS LLP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZELLESR-10
    Primary DI
    00860011967712
    Version / Model
    11.ZE10
    Catalog Number
    ZE10
    Company Name
    STERILE SAFEQUIP & CHEMICALS LLP
    Labeler DUNS
    876881873
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-07
    Public Version
    1
    Public Version Date
    2024-07-15
    Public Version Status
    New
    Public Device Record Key
    09bd63e5-d7b8-4f7e-afa4-5e992272de71

    Device Description

    Semi Automatic ESR Analyzer

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    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
    56691 Erthrocyte sedimentation rate (ESR) analyser IVD

    Identifiers

    Type ID
    Primary 00860011967712