BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    OV-A/P/N OxiVenT Sensor

    Reg #: 3004149774 · FEI: 3004149774 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SENTEC AG
    Registration Number
    3004149774
    FEI Number
    3004149774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RINGSTRASSE 39
    City
    THERWIL Basel-Landschaft
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K151329

    Owner / Operator

    Firm Name
    SENTEC AG
    Operator Number
    9064082
    Address
    RINGSTRASSE 39, --
    City
    THERWIL
    State
    Basel-Landschaft
    Postal Code
    CH-4106
    Country
    CH

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

    Device Name Product Code
    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Oximeter, Ear DPZ

    Proprietary Names

    OV-A/P/N OxiVenT Sensor EC-MI Ear Clip SenTec Digital Monitoring System V-STATS PC Software including V-CareNeT VS-A/P/N V-SignTM Sensor 2 MAR-MI Multi-site Attachment Ring MAR-SF Multi-site Attachment Ring SA-MAR Staysite Adhesive Pad MARe-SF Multi-Site Attachment Ring Easy PAK-MI Patient Application Kit for mature/intact skin PAK-SF Patient Application Kit for sensitive/fragile skin MR Membrane Changer PSG-A to PSG-X PSG Adapter Cables GEL-SD Single Dose Contact Gel MARe-MI Multi-Site Attachment Ring Easy MC Membrane Changer AC-250 Adapter Cable PAK-EC Patient Application Kit with Ear Clip for mature/intact skin GEL-04 Contact Gel AC-150 Adapter Cable SDM_WPC Sentec Water Protection Cover AC-750 Adapter Cable RFT100VA-V1 Isolation Transformer MC-I Membrane Changer Insert GAS-0812 Service Gas 103520 Non-Adhesive Wrap

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device