Propeller

Primary DI
00865528000082
Brand
Propeller
Company
RECIPROCAL LABS CORPORATION
Model
Sensor Model 2016-M-L
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.
Published
2017-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142516000Propeller SystemReciprocal Labs Corporation2015-05-15CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865528000082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865528000082008655280000828655280000820865528000082

GMDN Terms#

Term, Definition table
TermDefinition
Inhaler dose sensorA small, non-sterile, battery-powered device intended to be attached to a portable inhaler [e.g., metered dose inhaler (MDI), dry powder inhaler (DPI), soft mist inhaler (SMI)] to detect when a dose of inhaled medication has been taken, and to transmit this data wirelessly to a separate device (e.g., smartphone with appropriate software) to evaluate dosing interval. It is typically used in conjunction with software that may, e.g., set reminders. This is a single-patient reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968712278
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859105006345PropellerSensor Model 2018-S2021-05-26
00865528000099PropellerSensor Model 2017-B2018-09-11
00865528000013PropellerMDI 2 Sensor2016-07-22
00865528000020PropellerSensor Model 2014-R2016-07-22
00865528000037PropellerSensor Model 2014-D2016-07-22
00865528000068PropellerSensor Model 2015-E2017-01-16
00865528000075PropellerSensor Model 2016-M-S2017-12-21
00859105006000PropellerConvenience Kit - Mobile/SMII/SMII2016-07-22
00859105006017PropellerConvenience Kit - Mobile/SMII/SM2014-R2016-07-22
00859105006024PropellerConvenience Kit - Mobile/SMII/SM2014-D2016-07-22
00859105006031PropellerConvenience Kit - Mobile/SMII/SM2015-E2017-01-16
00859105006048PropellerConvenience Kit - HUB/SMII/SMII2016-07-22
00859105006055PropellerConvenience Kit - HUB/SMII/SM2014-R2016-07-22
00859105006062PropellerConvenience Kit - HUB/SMII/SM2014-D2016-07-22
00859105006079PropellerConvenience Kit - HUB/SMII/SM2015-E2017-01-16
00859105006086PropellerConvenience Kit - HUB/SMII2016-07-22
00859105006093PropellerConvenience Kit - HUB/SM2014-R2016-07-22
00859105006109PropellerConvenience Kit - HUB/SM2014-D2016-07-22
00859105006116PropellerConvenience Kit - Hub/SM2015-E2017-01-16
00859105006123PropellerConvenience Kit - Mobile/SM2016MS/SM2014R2018-01-30

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