BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Konmed

    DI: 06970935830338 · Model: CPR Mask in roll Model:KM-110 · 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
    06970935830338
    Version / Model
    CPR Mask in roll Model:KM-110
    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
    82817981-8c11-4488-adff-b8ea57e03268

    Device Description

    This Disposable shields roll with a low resistance filter that fits over manikin face; It can be protection students from insanitary risks when they're sharing a manikin in the CPR training class. The baterial filter efficiency is more than 95%,as same as N95 mask; Provide the customize logo and package service.

    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 06970935830338