BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PMI Probasics®

    DI: 00841447104018 · Model: 8005LP3 · COMPASS HEALTH BRANDS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PMI Probasics®
    Primary DI
    00841447104018
    Version / Model
    8005LP3
    Catalog Number
    8005LP3
    Company Name
    COMPASS HEALTH BRANDS CORP.
    Labeler DUNS
    827221698
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2023-09-04
    Public Version Status
    Update
    Public Device Record Key
    6073796c-261e-46f2-a79f-379208bb826e
    Distribution End Date
    2019-05-07

    Device Description

    Probasics Rite-Neb3 Mini Compressor Nebulizer

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAF Nebulizer (Direct Patient Interface)

    GMDN Terms

    Code Name
    35457 Benchtop nebulizer, non-heated

    Identifiers

    Type ID
    Package 20841447104012
    Primary 00841447104018
    Package 10841447104015

    Customer Contacts

    Phone
    800-376-7263
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K112824 000