BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Easy@Home KetoneTest Strips (150 test kit)

    DI: 00855944007222 · Model: EZR-101 · EASY HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    150

    Basic Information

    Brand Name
    Easy@Home KetoneTest Strips (150 test kit)
    Primary DI
    00855944007222
    Version / Model
    EZR-101
    Catalog Number
    EZR-101-150
    Company Name
    EASY HEALTHCARE CORPORATION
    Labeler DUNS
    080278407
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    150
    Record Status
    Published
    Publish Date
    2018-06-26
    Public Version
    1
    Public Version Date
    2018-07-27
    Public Version Status
    New
    Public Device Record Key
    230bfadf-d4aa-4512-aa7b-4afa2cf5ab8c

    Device Description

    Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 150 ct

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

    GMDN Terms

    Code Name
    53339 Ketone (acetoacetate) IVD, calibrator

    Identifiers

    Type ID
    Package 10855944007229
    Primary 00855944007222
    Unit of Use 30855944007223