BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vacuum Regulator

    DI: 00850027043456 · Model: PS300DHV SERIES w/ Vac Trap · Precision Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vacuum Regulator
    Primary DI
    00850027043456
    Version / Model
    PS300DHV SERIES w/ Vac Trap
    Company Name
    Precision Medical, Inc.
    Labeler DUNS
    112569116
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-27
    Public Version
    2
    Public Version Date
    2023-08-21
    Public Version Status
    Update
    Public Device Record Key
    5c60baad-cabe-4ee8-992a-2013c54c686c

    Device Description

    PS3300 SERIES, VAC REG, INTERMITTENT, OHMEDA X DISS MALE, TRAP

    Device Characteristics

    Single Use
    No
    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
    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
    KDP Regulator, Vacuum

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00850027043456

    Premarket Submissions

    Submission Number Supplement Number
    K944479 000