BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4"

    DI: 00020221078596 · Model: 37859S · Exel International
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4"
    Primary DI
    00020221078596
    Version / Model
    37859S
    Catalog Number
    37859S
    Company Name
    Exel International
    Labeler DUNS
    180572216
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-10
    Public Version
    1
    Public Version Date
    2023-04-18
    Public Version Status
    New
    Public Device Record Key
    9eb2796d-a380-404e-bd23-ce8b61b1b1b3

    Device Description

    EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4"; 20PCS/BOX, 160PCS/CASE

    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
    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
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    17180 Subcutaneous infusion/injection port needle

    Identifiers

    Type ID
    Package 10020221078593
    Primary 00020221078596
    Package 20020221078590

    Premarket Submissions

    Submission Number Supplement Number
    K012879 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius