BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Crit-Line®

    DI: 00840861101139 · Model: CL10041001 · Fresenius Usa, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Crit-Line®
    Primary DI
    00840861101139
    Version / Model
    CL10041001
    Company Name
    Fresenius Usa, Inc.
    Labeler DUNS
    076594100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-17
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    7d7329c8-ba00-4629-9363-c561bd623eaa

    Device Description

    Crit-Line in a Clip

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KOC ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

    GMDN Terms

    Code Name
    37218 Haemodialysis system blood volume monitor

    Identifiers

    Type ID
    Primary 00840861101139

    Customer Contacts

    Phone
    +1(801)451-9000
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 125 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 257 Degrees Fahrenheit