BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    PF 6001 Main Unit Complete

    Reg #: 8030885 · FEI: 3003244961 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    PERIMED AB
    Registration Number
    8030885
    FEI Number
    3003244961
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    DATAVAGEN 9 A
    City
    JARFALLA Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K131253

    Owner / Operator

    Firm Name
    PERIMED AB
    Operator Number
    8030885
    Address
    DATAVAGEN 9 A
    City
    JARFALLA
    State
    Stockholm
    Postal Code
    SE-175 43
    Country
    SE

    US Agent

    Business Name
    PERIMED, INC.
    Contact Name
    Samuel Pakvis
    Address
    7485 W Azure Drive, Suite 126
    City
    Las Vegas
    State
    NV
    ZIP
    89130
    Country
    US
    Email
    [email protected]
    Phone
    702 9874655 ext. 0

    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

    Proprietary Names

    PF 6001 Main Unit Complete PeriFlux System 6000 PeriFlux 6000 PF 6001 Main Unit PF 6040 tcpO2/pCO2 Unit PeriFlux 6000 tcpO2 Stand-alone PeriFlux 6000 tcpO2 System PF 6840-1 TC Remote Panel 1 Channel PF 6840-2 TC Remote Panel 2 Channels PF 6840-4 TC Remote Panel 4 Channels

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device