BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEADSTAR

    DI: 04711402231300 · Model: HS-8804 · HEADSTAR MEDICAL PRODUCTS CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HEADSTAR
    Primary DI
    04711402231300
    Version / Model
    HS-8804
    Company Name
    HEADSTAR MEDICAL PRODUCTS CO., LTD.
    Labeler DUNS
    658122049
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-27
    Public Version
    1
    Public Version Date
    2020-06-04
    Public Version Status
    New
    Public Device Record Key
    3ea9eca6-9b91-481d-9490-e9e8218c0066

    Device Description

    Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #4 Silicone mask with PSF dome for Small Adult Headstar offers anatomically designed face mask that brings maximum comfort to the patient.

    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 Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    BYG Mask, Oxygen

    GMDN Terms

    Code Name
    36066 Cardiopulmonary resuscitation mask, reusable

    Identifiers

    Type ID
    Primary 04711402231300