BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    *Mini-Heart® Lo-Flo Continuous Nebulizer W/Extension Set,7'

    DI: 00709078000218 · Model: 100616 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    *Mini-Heart® Lo-Flo Continuous Nebulizer W/Extension Set,7'
    Primary DI
    00709078000218
    Version / Model
    100616
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-06
    Public Version
    5
    Public Version Date
    2024-02-29
    Public Version Status
    Update
    Public Device Record Key
    9f5b0f58-d7eb-45a6-9da1-a54310fe932d
    Distribution End Date
    2024-02-29

    Device Description

    *Mini-Heart® Lo-Flo Continuous Nebulizer W/Extension Set,7'

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    31309 Nebulizing system delivery set, single-use

    Identifiers

    Type ID
    Package 10709078000215
    Primary 00709078000218

    Premarket Submissions

    Submission Number Supplement Number
    K920443 000