BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VOCSN O2 Low Pressure Inlet

    DI: 00855573007396 · Model: 10-Pack · VENTEC LIFE SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    VOCSN O2 Low Pressure Inlet
    Primary DI
    00855573007396
    Version / Model
    10-Pack
    Catalog Number
    PRT-00981-000
    Company Name
    VENTEC LIFE SYSTEMS, INC.
    Labeler DUNS
    078758082
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2018-07-13
    Public Version
    2
    Public Version Date
    2019-01-31
    Public Version Status
    Update
    Public Device Record Key
    6ab8e7c7-f9d8-4761-9124-c5d52bf9348b

    Device Description

    VOCSN O2 Low Pressure Inlet, 10-Pack

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CBK Ventilator, Continuous, Facility Use
    NOU Continuous, Ventilator, Home Use

    GMDN Terms

    Code Name
    47083 Portable electric ventilator

    Identifiers

    Type ID
    Primary 00855573007396
    Unit of Use 00855573007518

    Premarket Submissions

    Submission Number Supplement Number
    K162877 000