BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Konmed

    DI: 06970935830284 · Model: CPR Mask Keyring Mode:KM-101 · Shenzhen Konmed Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Konmed
    Primary DI
    06970935830284
    Version / Model
    CPR Mask Keyring Mode:KM-101
    Company Name
    Shenzhen Konmed Technology Co., Ltd.
    Labeler DUNS
    544436531
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b7220db4-101f-479a-ab3d-2fca0434bf9d

    Device Description

    KM-101 is a quick, inexpensive, easy to use resuscitation sheet with a one-way valve meant to provide a safe barrier between you and your patient. This CPR mask prevents your mouth, nose and face from coming into direct contact with the other person and is designed to stay securely in place during the procedure.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BYP Mouthpiece, Breathing

    GMDN Terms

    Code Name
    61326 Cardiopulmonary resuscitation mask, single-use

    Identifiers

    Type ID
    Primary 06970935830284