BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Disposable Anesthesia Breathing Circuit

    DI: 00709078009525 · Model: 8625 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Anesthesia Breathing Circuit
    Primary DI
    00709078009525
    Version / Model
    8625
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    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
    ad6b4113-ad76-4bda-9b61-76c25008a779
    Distribution End Date
    2023-08-11

    Device Description

    Anesthesia Circuit, Pediatric, 96" Expandable, GSE w/Cap, Parallel Wye, GSL 10' x .060" ID M/M 2L Not Made With Latex Breathing Bag, B/V Filter, In-Line Mini HME

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

    GMDN Terms

    Code Name
    37704 Anaesthesia breathing circuit, single-use

    Identifiers

    Type ID
    Package 10709078009522
    Primary 00709078009525

    Premarket Submissions

    Submission Number Supplement Number
    K922492 000