BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anesthesia/Breathing Circuits

    DI: 00709078014512 · Model: 9700 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anesthesia/Breathing Circuits
    Primary DI
    00709078014512
    Version / Model
    9700
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-31
    Public Version
    2
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    52c58ab8-9e8b-49cc-bcf6-5ba467d2555e

    Device Description

    120" Adult 22mm/2mm Expandable Circuit, Parallel WYE, 2() B/V Filters, Mini HEMF W/ CO2 Port, Adult Vent Mask, 2L not made with latex breathing bag, Sterile Yankuer, W/Bulb Tip, 10' x 0.050 M/M GSL, 10' Suction Tubing

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    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 10709078014519
    Primary 00709078014512

    Premarket Submissions

    Submission Number Supplement Number
    K922492 000