BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sodium Bicarbonate Mixing and Distribution System

    DI: 00852456007085 · Model: IsoMix PRO · Isopure, Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sodium Bicarbonate Mixing and Distribution System
    Primary DI
    00852456007085
    Version / Model
    IsoMix PRO
    Company Name
    Isopure, Corp.
    Labeler DUNS
    040279650
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-20
    Public Version
    4
    Public Version Date
    2023-08-31
    Public Version Status
    Update
    Public Device Record Key
    464d5635-080f-431f-8285-555807df6977

    Device Description

    IsoMix PRO Sodium Bicarbonate Mixing and Distribution System (MD702480-SS)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No

    Product Codes

    Code Name
    FIN Tank, Holding, Dialysis

    GMDN Terms

    Code Name
    36342 Haemodialysis system fluid mixer

    Identifiers

    Type ID
    Primary 00852456007085

    Premarket Submissions

    Submission Number Supplement Number
    K112427 000