BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bio-Med Devices, Inc.

    DI: 00813841020140 · Model: 2002F70D · BIO-MED DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bio-Med Devices, Inc.
    Primary DI
    00813841020140
    Version / Model
    2002F70D
    Catalog Number
    2002F70D
    Company Name
    BIO-MED DEVICES, INC.
    Labeler DUNS
    116167966
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-11-02
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    503b3db0-9f19-48aa-82fe-3232582967ab

    Device Description

    Air / Oxygen Blender high flow with flowmeter

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MOD Accessory To Continuous Ventilator (Respirator)

    GMDN Terms

    Code Name
    44225 Oxygen/air breathing gas mixer, hospital

    Identifiers

    Type ID
    Primary 00813841020140

    Customer Contacts

    Phone
    203-458-0202
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K925982 000