BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Smart Anemia Manager (SAM)

    DI: 00860005737512 · Model: 1 · Dosis Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Smart Anemia Manager (SAM)
    Primary DI
    00860005737512
    Version / Model
    1
    Company Name
    Dosis Inc.
    Labeler DUNS
    968916627
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-09
    Public Version
    1
    Public Version Date
    2021-03-17
    Public Version Status
    New
    Public Device Record Key
    9ee56ff8-8e67-4e7a-813e-687bea3ed321

    Device Description

    SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia.

    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
    No
    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
    MQS System, Hemodialysis, Access Recirculation Monitoring

    GMDN Terms

    Code Name
    41049 Nephrology information system application software

    Identifiers

    Type ID
    Primary 00860005737512