BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OLYMPUS EndoTherapy™ Inflation Device

    DI: 00856877002520 · Model: QL6015 · ATRION MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OLYMPUS EndoTherapy™ Inflation Device
    Primary DI
    00856877002520
    Version / Model
    QL6015
    Catalog Number
    MAJ-1740-D
    Company Name
    ATRION MEDICAL PRODUCTS, INC.
    Labeler DUNS
    047571476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    6
    Public Version Date
    2021-01-08
    Public Version Status
    Update
    Public Device Record Key
    c18ba1f8-024c-47bb-a3ec-dba6eeaa77e3

    Device Description

    Inflation Device Atrion Part Number 96318: 60mL, 15atm

    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
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MAV Syringe, Balloon Inflation
    KOE Dilator, Urethral

    GMDN Terms

    Code Name
    17541 Catheter/overtube balloon inflator, single-use

    Identifiers

    Type ID
    Primary 00856877002520

    Customer Contacts

    Phone
    +1(800)343-9334
    Email
    [email protected]