BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Lavage Procedure Kit

    DI: 08719992086016 · Model: 1 · Eight Medical International B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lavage Procedure Kit
    Primary DI
    08719992086016
    Version / Model
    1
    Company Name
    Eight Medical International B.V.
    Labeler DUNS
    490348632
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-10
    Public Version
    2
    Public Version Date
    2022-12-07
    Public Version Status
    Update
    Public Device Record Key
    9c46127d-59c2-41bd-b623-81d5034e0834
    Distribution End Date
    2022-04-30

    Device Description

    The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LGZ Warmer, Thermal, Infusion Fluid

    GMDN Terms

    Code Name
    40796 Extravascular-circulation hyperthermia system applicator, intracorporeal

    Identifiers

    Type ID
    Primary 08719992086016