BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Disposable Circuit

    DI: 00709078012280 · Model: 8306 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    Disposable Circuit
    Primary DI
    00709078012280
    Version / Model
    8306
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2020-09-30
    Public Version
    4
    Public Version Date
    2023-08-11
    Public Version Status
    Update
    Public Device Record Key
    3e458e0a-e83c-419b-b8ba-5c51d77efc94
    Distribution End Date
    2023-08-11

    Device Description

    Circuit, Disposable, 15mm, Non Heated, Dual Limb (20 pack)

    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
    No
    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
    Unit of Use 10709078012294
    Primary 00709078012280

    Premarket Submissions

    Submission Number Supplement Number
    K922492 000