BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAMI RRT Cassette

    DI: B815SA400000 · Model: SA-400-00 · Dialco Medical Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SAMI RRT Cassette
    Primary DI
    B815SA400000
    Version / Model
    SA-400-00
    Catalog Number
    SA-400-00
    Company Name
    Dialco Medical Inc
    Labeler DUNS
    203940515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-09
    Public Version
    2
    Public Version Date
    2021-02-15
    Public Version Status
    Update
    Public Device Record Key
    6bdfc835-a56e-4cca-bb63-f256a3a4de9b

    Device Description

    The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.

    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
    Yes
    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
    34999 Haemodialysis blood tubing set, single-use

    Identifiers

    Type ID
    Primary B815SA400000

    Customer Contacts

    Phone
    18884264264
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    5 – 30 Degrees Celsius
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Storage Environment Temperature
    Temperature Range
    5 – 30 Degrees Celsius