BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surgical Free Flow Vacuum Regulator

    DI: 00628101609221 · Model: SCHA · OHIO MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Surgical Free Flow Vacuum Regulator
    Primary DI
    00628101609221
    Version / Model
    SCHA
    Company Name
    OHIO MEDICAL, LLC
    Labeler DUNS
    005192885
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-30
    Public Version
    1
    Public Version Date
    2020-05-08
    Public Version Status
    New
    Public Device Record Key
    f1f3a930-4229-41ac-a6df-b85bde0b4cfa

    Device Description

    Vacuum Regulator, Surgical Free Flow, 760mmHg Analog

    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
    GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

    GMDN Terms

    Code Name
    44809 Vacuum suction regulator/regulation set, general-purpose

    Identifiers

    Type ID
    Primary 00628101609221
    Previous 08688250002238

    Customer Contacts

    Phone
    18478550500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K861261 000