BEUDAMED
    FDA Registration Active 🇺🇸 United States

    86145 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4.5 mm)

    Reg #: 2936999 · FEI: 2936999 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Covidien
    Registration Number
    2936999
    FEI Number
    2936999
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Medtronic Dr
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223130

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

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

    Proprietary Names

    86145 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4.5 mm) 86135 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (3.5 mm) 86150 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (5 mm) Shiley Pediatric Oral/Nasal ETT with TaperGuard Cuff 86130 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (3 mm) 86140 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4 mm) 86155 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (5.5 mm) 86160 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (6 mm) 86125 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (2.5 mm)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility