BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VADI

    DI: 04719894380926 · Model: G-316002 · VADI MEDICAL TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VADI
    Primary DI
    04719894380926
    Version / Model
    G-316002
    Catalog Number
    G-316002-CFS
    Company Name
    VADI MEDICAL TECHNOLOGY CO., LTD.
    Labeler DUNS
    657254280
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-16
    Public Version
    1
    Public Version Date
    2023-10-24
    Public Version Status
    New
    Public Device Record Key
    9b65fb8f-e71f-4dd0-9eeb-95badd6e745e

    Device Description

    Disposable ventilator circuit/ tubing (Without heated wire)

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZO Set, Tubing And Support, Ventilator (W Harness)

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Package 14719894380923
    Primary 04719894380926

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 60 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 95 Percent (%) Relative Humidity