BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UniFlow™ Coaxial Breathing System

    DI: 00816472023061 · Model: 29026000 · Intersurgical Incorporated
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UniFlow™ Coaxial Breathing System
    Primary DI
    00816472023061
    Version / Model
    29026000
    Company Name
    Intersurgical Incorporated
    Labeler DUNS
    785952607
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-04
    Public Version
    1
    Public Version Date
    2023-05-12
    Public Version Status
    New
    Public Device Record Key
    5fd74219-623b-475d-a30c-d070ae9ee96d

    Device Description

    UniFlow™ Coaxial Breathing System 30mm with Integrated Monitor Line 0.5M Limb, 1.6M

    Device Characteristics

    Single Use
    Yes
    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

    GMDN Terms

    Code Name
    37021 Anaesthesia breathing circuit, reusable

    Identifiers

    Type ID
    Package 00816472023078
    Primary 00816472023061