BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 03596010121202 · Model: 3982G · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    03596010121202
    Version / Model
    3982G
    Catalog Number
    3982G
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-30
    Public Version
    6
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    abdd5aa5-1543-4a81-a287-12d172f6d656

    Device Description

    LEVELERT SENSOR ASSY GERMAN

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FLN MONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS

    GMDN Terms

    Code Name
    11010 Electronic gravity infusion controller

    Identifiers

    Type ID
    Primary 03596010121202

    Customer Contacts

    Phone
    +1(800)821-5700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K903193 000