BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GYRUS ACMI, INC

    DI: 00821925033184 · Model: BD-400P-1380 · Gyrus Acmi, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GYRUS ACMI, INC
    Primary DI
    00821925033184
    Version / Model
    BD-400P-1380
    Company Name
    Gyrus Acmi, Inc.
    Labeler DUNS
    007198742
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-04
    Public Version
    3
    Public Version Date
    2023-11-22
    Public Version Status
    Update
    Public Device Record Key
    2c499bf6-7540-4b39-9c98-cdaaa2a2b3ed

    Device Description

    EZDilate - Fixed Wire Esophageal 3-Stage Balloon Dilatation Catheter

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNQ Dilator, esophageal

    GMDN Terms

    Code Name
    10747 Cardiac septostomy catheter, balloon

    Identifiers

    Type ID
    Primary 00821925033184