BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ROCAFLOW Irrigation, Warming and Suction System

    DI: 03700512955269 · Model: U00000023140 · Promepla
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ROCAFLOW Irrigation, Warming and Suction System
    Primary DI
    03700512955269
    Version / Model
    U00000023140
    Catalog Number
    MEN02PUS
    Company Name
    Promepla
    Labeler DUNS
    401020409
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-18
    Public Version
    2
    Public Version Date
    2019-11-11
    Public Version Status
    Update
    Public Device Record Key
    01ffbc7a-cb1d-402f-a214-6d527d946548

    Device Description

    ROCAFLOW US SINGLE CHAMBER WITH SUCTION PUMP FOR OLYMPUS

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCX Endoscopic Irrigation/Suction System

    GMDN Terms

    Code Name
    41978 Surgical irrigation/aspiration system

    Identifiers

    Type ID
    Primary 03700512955269
    Package 03700512956266