BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA

    DI: 00857335005077 · Model: 2.0 · Otsuka America Pharmaceutical Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
    Primary DI
    00857335005077
    Version / Model
    2.0
    Company Name
    Otsuka America Pharmaceutical Inc
    Labeler DUNS
    008314390
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-19
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d2a5eb26-05ae-44d1-9c97-87beddaadc26

    Device Description

    The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    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
    OZA Test, Urea Adult And Pediatric (Breath),

    GMDN Terms

    Code Name
    52787 Helicobacter pylori urease IVD, kit, chromogenic

    Identifiers

    Type ID
    Primary 00857335005077

    Premarket Submissions

    Submission Number Supplement Number
    P100025 000