Duns Number:968712278
Device Description: The Propeller System includes the Propeller SMI Model 2014-R Sensor. The sensor is an acce The Propeller System includes the Propeller SMI Model 2014-R Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed SMI 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 SMI 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 SMI, 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 SMI technique.When used under the care of a physician with a prescribed SMI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to SMI 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.
Catalog Number
-
Brand Name
Propeller
Version/Model Number
Sensor Model 2014-R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142960
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
4927bc8c-3ea6-4bea-b405-605acb7ba3d8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |