BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Propeller

    DI: 00865528000075 · Model: Sensor Model 2016-M-S · RECIPROCAL LABS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Propeller
    Primary DI
    00865528000075
    Version / Model
    Sensor Model 2016-M-S
    Company Name
    RECIPROCAL LABS CORPORATION
    Labeler DUNS
    968712278
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-21
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    72ef111a-9902-4e9c-a0ab-6dbc4af39c88

    Device Description

    The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers. When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique. When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education. The Propeller System is intended to be used in populations from Child (>2 years) to adult. The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    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
    61866 Inhaler dose sensor

    Identifiers

    Type ID
    Primary 00865528000075

    Premarket Submissions

    Submission Number Supplement Number
    K142516 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 60 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    0 – 55 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    15 – 140 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    32 – 130 Degrees Fahrenheit
    Type
    Handling Environment Humidity
    Temperature Range
    5 – 95 Percent (%) Relative Humidity