BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NeoPIP Infant Resuscitator Universal Mounting Bracket

    DI: 00854401006396 · Model: NF-101U · FLEXICARE MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NeoPIP Infant Resuscitator Universal Mounting Bracket
    Primary DI
    00854401006396
    Version / Model
    NF-101U
    Company Name
    FLEXICARE MEDICAL LIMITED
    Labeler DUNS
    504406273
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-11
    Public Version
    2
    Public Version Date
    2023-08-16
    Public Version Status
    Update
    Public Device Record Key
    34da1a10-7e75-4ad6-bb91-9b743e137b51
    Distribution End Date
    2023-02-16

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BTM Ventilator, Emergency, Manual (Resuscitator)

    GMDN Terms

    Code Name
    13366 Pulmonary resuscitator, pneumatic, reusable

    Identifiers

    Type ID
    Primary 00854401006396

    Premarket Submissions

    Submission Number Supplement Number
    K072021 000