BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bacterial-Viral HME Filter

    DI: M485AL08021V0011 · Model: AL-08021.V001 · 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
    Bacterial-Viral HME Filter
    Primary DI
    M485AL08021V0011
    Version / Model
    AL-08021.V001
    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
    2023-08-10
    Public Version
    1
    Public Version Date
    2023-08-18
    Public Version Status
    New
    Public Device Record Key
    28e6c0c0-e0ca-47a1-bb2b-7b2e2f3d626a

    Device Description

    A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. 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
    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

    GMDN Terms

    Code Name
    46816 Heat/moisture exchanger/microbial medical gas filter

    Identifiers

    Type ID
    Package M485AL08021V0012
    Primary M485AL08021V0011

    Premarket Submissions

    Submission Number Supplement Number
    K192713 000

    Storage Conditions

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