BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OneTouch Ultra Blue Test Strips

    Reg #: 3009698388 · FEI: 2939301 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Lifescan, Inc.
    Registration Number
    3009698388
    FEI Number
    2939301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    75 Valley Stream Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053529

    Owner / Operator

    Firm Name
    LIFESCAN, INC.
    Operator Number
    2919025
    Address
    75 Valley Stream Parkway, --
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    OneTouch Ultra Blue Test Strips OneTouch Ultra 2 Meter OneTouch Ultra 2 Blood Glucose Monitoring System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility