BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tamper Evident Cap with Male Luer Lock

    DI: B2125791R1 · Model: 57-91 R · INTERNATIONAL MEDICAL INDUSTRIES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tamper Evident Cap with Male Luer Lock
    Primary DI
    B2125791R1
    Version / Model
    57-91 R
    Catalog Number
    57-91 R
    Company Name
    INTERNATIONAL MEDICAL INDUSTRIES INC.
    Labeler DUNS
    053469565
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-13
    Public Version
    2
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    32ea9297-7f9e-4e3d-b5d0-9b9a0dd44287

    Device Description

    Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access and maintains sterility. 1 Cap per sterile blister, 100 caps per shipper box

    Device Characteristics

    Single Use
    Yes
    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
    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
    58977 Basic intravenous administration set, noninvasive

    Identifiers

    Type ID
    Package B2125791R2
    Primary B2125791R1

    Premarket Submissions

    Submission Number Supplement Number
    K182545 000