BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    In-Line Gas Warmer

    DI: 00817183020233 · Model: 6-820-00 · NORTHGATE TECHNOLOGIES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    In-Line Gas Warmer
    Primary DI
    00817183020233
    Version / Model
    6-820-00
    Company Name
    NORTHGATE TECHNOLOGIES INC.
    Labeler DUNS
    627969264
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-13
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    73fdeaa6-7b13-4a04-a41b-09fabf064f0e

    Device Description

    In-Line gas warmer is for use with laparoscopic insufflators

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    HIF Insufflator, Laparoscopic

    GMDN Terms

    Code Name
    48169 Insufflation gas conditioning system control unit

    Identifiers

    Type ID
    Primary 00817183020233

    Premarket Submissions

    Submission Number Supplement Number
    K992381 000