BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Resuscitation Face Mask Single Use Round Silicone Neonatal Size 0

    DI: 00854401006570 · Model: NF-160-10U · FLEXICARE MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resuscitation Face Mask Single Use Round Silicone Neonatal Size 0
    Primary DI
    00854401006570
    Version / Model
    NF-160-10U
    Company Name
    FLEXICARE MEDICAL LIMITED
    Labeler DUNS
    504406273
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-30
    Public Version
    2
    Public Version Date
    2023-08-16
    Public Version Status
    Update
    Public Device Record Key
    9e4cccd3-12c6-473e-8ce5-9039c79a60ef
    Distribution End Date
    2023-02-16

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    BYG Mask, Oxygen

    GMDN Terms

    Code Name
    61326 Cardiopulmonary resuscitation mask, single-use

    Identifiers

    Type ID
    Primary 00854401006570