BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aerotech I Radioaerosol Administration System

    DI: 00718175087633 · Model: 177-095 · BIODEX MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aerotech I Radioaerosol Administration System
    Primary DI
    00718175087633
    Version / Model
    177-095
    Catalog Number
    177-095
    Company Name
    BIODEX MEDICAL SYSTEMS, INC.
    Labeler DUNS
    043833813
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-15
    Public Version
    1
    Public Version Date
    2020-10-23
    Public Version Status
    New
    Public Device Record Key
    1ce34115-c4f5-4f30-9d52-849ca3e577a5

    Device Description

    AeroTech I Shield

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    16784 Radioaerosol administration set

    Identifiers

    Type ID
    Primary 00718175087633

    Premarket Submissions

    Submission Number Supplement Number
    K800023 000