BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Endotracheal Tube, Preformed, oral, uncuffed (PFOU)

    Reg #: 3004748541 · FEI: 3004748541 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Salter Labs
    Registration Number
    3004748541
    FEI Number
    3004748541
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    30 Spur Drive
    City
    El Paso
    State
    TX
    ZIP
    79906
    Country
    US

    Regulatory Submissions

    510(k) Number
    K984528

    Owner / Operator

    Firm Name
    SunMed
    Operator Number
    9038422
    Address
    2710 Northridge Drive NW, Suite A
    City
    Grand Rapids
    State
    MI
    Postal Code
    49544
    Country
    US
    Correspondent
    Rob Yamashita

    Products

    Device Name Product Code
    Tube, Tracheal (W/Wo Connector) BTR

    Proprietary Names

    Endotracheal Tube, Preformed, oral, uncuffed (PFOU) Endotracheal Tube, High vol, low pressure (PFHV) cuffed, pre-loaded with sheathed stylet (PFST) Micro-laryngeal tube, Parker flex-tip (PMLT) EasyCurve Endotracheal tube, articulating cord, cuffed (PFEC) Endotracheal Tube, uncuffed (PFUO) Endotracheal Tube, Reinforced, un-cuffed (PFRU) Endotracheal Tube, Polyurethance, Thin cuff (PTCL) Endotracheal Tube, Endotrachael Tube, Low profile, cuffed (PFLP) Endotrachael Tube, High Volume, Low Pressure, Cuffed (PFHV) Endotracheal Tube, Reinforced, cuffed (PFRC) Endotrachael tube, Preformed, Oral, cuffed (PFOC) Endotracheal Tube, Preformed oral, Cuffed, low Profile (PFOL) Endotracheal Tube, Polyurethane, Thincuff, (PTCY) Parker Standard Tip Endobronchial (PSTDR) Endotracheal Tube, High volume Low Pressure, cuffed (PFST) Parker Standard Tip Endobronchial PSTDL Endotracheal Tube, preformed, Nasal, Uncuffed (PFNU) Endotracheal Tube, preformed, Nasal, cuffed (PFNC)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility