BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Renaflo II Hemofilter

    DI: 00677964000072 · Model: HF 700 · MEDIVATORS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Renaflo II Hemofilter
    Primary DI
    00677964000072
    Version / Model
    HF 700
    Catalog Number
    93024131
    Company Name
    MEDIVATORS INC.
    Labeler DUNS
    068199363
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    6
    Public Version Date
    2023-07-19
    Public Version Status
    Update
    Public Device Record Key
    034207da-a159-4329-918b-2494282c160d

    Device Description

    Renaflo II Hemofilter HF 700

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

    GMDN Terms

    Code Name
    44601 Haemofilter

    Identifiers

    Type ID
    Package 30677964000073
    Primary 00677964000072

    Customer Contacts

    Phone
    +1(800)444-4729
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K923312 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    20 – 30 Degrees Celsius