BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 04961333231188 · Model: 1111-1582 · 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
    04961333231188
    Version / Model
    1111-1582
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-07
    Public Version
    5
    Public Version Date
    2019-11-08
    Public Version Status
    Update
    Public Device Record Key
    f59fd3b1-049a-4db3-8a70-5679bab39fc4

    Device Description

    ANALOG-DIGITAL CONVERT DFG/SV1

    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
    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
    No

    Product Codes

    Code Name
    KLA Monitor, Esophageal Motility, And Tube

    GMDN Terms

    Code Name
    35053 Manometric gastrointestinal motility analysis system

    Identifiers

    Type ID
    Primary 04961333231188

    Premarket Submissions

    Submission Number Supplement Number
    K954798 000