BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OLpur MD 220 - FDA

    DI: 00896241002053 · Model: 70-1220 · NEPHROS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OLpur MD 220 - FDA
    Primary DI
    00896241002053
    Version / Model
    70-1220
    Company Name
    NEPHROS, INC.
    Labeler DUNS
    120664557
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2021-09-17
    Public Version Status
    Update
    Public Device Record Key
    b19e7665-fcf5-499a-afc0-7dafbaf10444

    Device Description

    OLpur MD 220 - FDA and packaging information

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FIP Subsystem, Water Purification

    GMDN Terms

    Code Name
    61138 Legionella water purification filter, non-sterile

    Identifiers

    Type ID
    Package 20896241002057
    Package 10896241002050
    Primary 00896241002053

    Premarket Submissions

    Submission Number Supplement Number
    K112314 000