BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FlexTube

    DI: 07540198003023 · Model: Connector · Prime Pacific Health Innovations Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    FlexTube
    Primary DI
    07540198003023
    Version / Model
    Connector
    Catalog Number
    8232-50
    Company Name
    Prime Pacific Health Innovations Corporation
    Labeler DUNS
    250896255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2023-10-27
    Public Version
    1
    Public Version Date
    2023-11-06
    Public Version Status
    New
    Public Device Record Key
    11f6e91c-df01-433d-9c57-94c73108db4f

    Device Description

    The FlexTube is a connector intended to be used with the AquaWing Treatment Table. It fits the flow-through fitting of the table and allows water to pass through the portion of the table that supports the patients legs during treatment.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No

    Product Codes

    Code Name
    GCD Connector, Catheter

    GMDN Terms

    Code Name
    60538 Luer/Luer linear connector, single-use

    Identifiers

    Type ID
    Unit of Use 07540198003115
    Primary 07540198003023