BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TabloCart™ with Prefiltration Drawer

    DI: 00850001011297 · Model: PN-0006988 · Outset Medical, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TabloCart™ with Prefiltration Drawer
    Primary DI
    00850001011297
    Version / Model
    PN-0006988
    Company Name
    Outset Medical, Inc.
    Labeler DUNS
    788744477
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-17
    Public Version
    2
    Public Version Date
    2025-05-14
    Public Version Status
    Update
    Public Device Record Key
    b912ab2d-8e92-476f-a1cc-97e7687cf89b

    Device Description

    Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System

    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
    MR Unsafe
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
    FIP Subsystem, Water Purification

    GMDN Terms

    Code Name
    44344 Combination water purification system

    Identifiers

    Type ID
    Primary 00850001011297

    Premarket Submissions

    Submission Number Supplement Number
    K232776 000