BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioPure 4400 RO

    DI: 00817492021938 · Model: 42M16B2F · MAR COR PURIFICATION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioPure 4400 RO
    Primary DI
    00817492021938
    Version / Model
    42M16B2F
    Company Name
    MAR COR PURIFICATION, INC.
    Labeler DUNS
    019056181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-19
    Public Version
    2
    Public Version Date
    2019-02-26
    Public Version Status
    Update
    Public Device Record Key
    c47b35b4-c543-4307-9021-ace44f6842f5

    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
    No

    Product Codes

    Code Name
    FIP Subsystem, Water Purification

    GMDN Terms

    Code Name
    14437 Reverse-osmosis water purification system

    Identifiers

    Type ID
    Primary 00817492021938

    Customer Contacts

    Phone
    8002685035
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Weight 506 Pound
    Height 80.5 Inch
    Depth 29 Inch
    Width 38 Inch

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    32 – Degrees Fahrenheit