BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anesthesia Circuit Kit

    DI: 10889483608975 · Model: 9803 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anesthesia Circuit Kit
    Primary DI
    10889483608975
    Version / Model
    9803
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-20
    Public Version
    1
    Public Version Date
    2023-12-28
    Public Version Status
    New
    Public Device Record Key
    74977663-d8cd-42ab-99a4-69809e59e66f

    Device Description

    60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L latex-free breathing bag, disposable, med mask

    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
    Yes
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAH Filter, Bacterial, Breathing-Circuit
    OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)

    GMDN Terms

    Code Name
    37704 Anaesthesia breathing circuit, single-use

    Identifiers

    Type ID
    Package 30889483608979
    Primary 10889483608975

    Premarket Submissions

    Submission Number Supplement Number
    K922492 000