BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Standard Breathing Circuit with Face Mask - Toddler

    DI: 08697645013520 · Model: BC21086 · MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Standard Breathing Circuit with Face Mask - Toddler
    Primary DI
    08697645013520
    Version / Model
    BC21086
    Company Name
    MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
    Labeler DUNS
    565424848
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-30
    Public Version
    1
    Public Version Date
    2023-07-10
    Public Version Status
    New
    Public Device Record Key
    40fc46c7-9351-40f7-8a24-de7f5e975a2a

    Device Description

    An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

    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
    Yes
    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
    CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Primary 08697645013520
    Package 68697645013744

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 40 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 70 Percent (%) Relative Humidity