BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    inCourage®

    DI: 00841561102778 · Model: ICS-1M-US · RESPIRATORY TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    inCourage®
    Primary DI
    00841561102778
    Version / Model
    ICS-1M-US
    Company Name
    RESPIRATORY TECHNOLOGIES, INC.
    Labeler DUNS
    847990566
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-10
    Public Version
    4
    Public Version Date
    2019-12-11
    Public Version Status
    Update
    Public Device Record Key
    020dbb4c-8d0d-4bfe-94cb-22cca30ba5e0

    Device Description

    Pulsating Therapy Unit

    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
    BYI Percussor, Powered-Electric

    GMDN Terms

    Code Name
    38123 Chest-oscillation airway secretion-clearing system generator

    Identifiers

    Type ID
    Primary 00841561102778

    Customer Contacts

    Phone
    1-800-793-1261
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K051383 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -25 – 85 Degrees Celsius