BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SOMAVAC 100 Sustained Vacuum System

    DI: 00850004219027 · Model: 10011 · SOMAVAC MEDICAL SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SOMAVAC 100 Sustained Vacuum System
    Primary DI
    00850004219027
    Version / Model
    10011
    Catalog Number
    10011
    Company Name
    SOMAVAC MEDICAL SOLUTIONS, INC.
    Labeler DUNS
    080446796
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-30
    Public Version
    2
    Public Version Date
    2021-03-24
    Public Version Status
    Update
    Public Device Record Key
    6039a784-bcd1-49b0-b401-2a8b9ae751e5

    Device Description

    Portable, battery powered vacuum source with waste containers and accessories.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
    BTA Pump, Portable, Aspiration (Manual Or Powered)

    GMDN Terms

    Code Name
    64400 Closed-wound drainage suction pump

    Identifiers

    Type ID
    Primary 00850004219027

    Premarket Submissions

    Submission Number Supplement Number
    K180606 000