BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 04961333244188 · Model: OS-H5 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    04961333244188
    Version / Model
    OS-H5
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-15
    Public Version
    2
    Public Version Date
    2019-11-27
    Public Version Status
    Update
    Public Device Record Key
    c5d78b44-2380-4379-a606-05fa52ca658c

    Device Description

    WATER BOTTLE, REUSABLE

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Sound Waves"]

    Product Codes

    Code Name
    PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement

    GMDN Terms

    Code Name
    61156 Endoscopic irrigation/distension bottle

    Identifiers

    Type ID
    Primary 04961333244188