BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Altera

    DI: 00744229678052 · Model: 678G8000 · PARI RESPIRATORY EQUIPMENT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Altera
    Primary DI
    00744229678052
    Version / Model
    678G8000
    Company Name
    PARI RESPIRATORY EQUIPMENT, INC.
    Labeler DUNS
    804736098
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-26
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    5345dc92-7a14-457c-a031-488be70812cf

    Device Description

    Altera Nebulizer Handset

    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
    CAF Nebulizer (Direct Patient Interface)

    GMDN Terms

    Code Name
    12719 Ultrasonic nebulizing system

    Identifiers

    Type ID
    Package 00744229678311
    Primary 00744229678052

    Premarket Submissions

    Submission Number Supplement Number
    K100380 000