BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Infant Resuscitation Kit T-Piece Circuit

    DI: 00854401006501 · Model: NF-157-1U · FLEXICARE MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Infant Resuscitation Kit T-Piece Circuit
    Primary DI
    00854401006501
    Version / Model
    NF-157-1U
    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
    4
    Public Version Date
    2023-08-16
    Public Version Status
    Update
    Public Device Record Key
    84338041-0915-44e8-8684-128c759293ab
    Distribution End Date
    2023-02-16

    Device Description

    1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 1

    Device Characteristics

    Single Use
    Yes
    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
    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
    BYE Attachment, Breathing, Positive End Expiratory Pressure

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Primary 00854401006501

    Premarket Submissions

    Submission Number Supplement Number
    K103833 000