Propeller

GUDID 00865528000075

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.

RECIPROCAL LABS CORPORATION

Inhaler dose sensor

• Primary Device ID: 00865528000075
• NIH Device Record Key: 72ef111a-9902-4e9c-a0ab-6dbc4af39c88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Propeller
• Version Model Number: Sensor Model 2016-M-S
• Company DUNS: 968712278
• Company Name: RECIPROCAL LABS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865528000075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142516

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-21

On-Brand Devices [Propeller]

• 00865528000099: Model 2017-B. The sensor is an accessory device intended for single-patient use to assist physic
• 00865528000082: The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory de
• 00865528000075: The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory de
• 00865528000068: The Propeller System includes the Propeller Sensor Model 2015-E. The sensor is an accessory devi
• 00865528000037: The Propeller System includes the Propeller DPI Model 2014-D Sensor. The sensor is an accessory
• 00865528000020: The Propeller System includes the Propeller SMI Model 2014-R Sensor. The sensor is an accessory
• 00865528000013: The Propeller System includes the Propeller MDI Model 2 OTC Sensor. The sensor is an accessory d
• 00859105006338: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006321: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006314: The convenience kit contains the following products: 2 x Propeller Sensor Model 2016-M-L (GTIN-1
• 00859105006307: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006291: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006284: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006277: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006260: The convenience kit contains the following products: 2 x Propeller Sensor Model 2016-M-L (GTIN-1
• 00859105006246: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006239: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006222: The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 0
• 00859105006215: The convenience kit contains the following products: Propeller Sensor Model 2016-M-S: (GTIN-14:
• 00859105006208: The convenience kit contains the following products: Two (2) x Propeller Sensor Model 2016-M-S d
• 00859105006192: The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 0
• 00859105006185: The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 0
• 00859105006178: The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 0
• 00859105006161: The convenience kit contains the following products: (2x) Propeller Sensor Model 2016-M-S (GTIN-
• 00859105006147: The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 0
• 00859105006130: The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 0
• 00859105006123: The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 0
• 00859105006116: The convenience kit contains the following products: Propeller Sensor Model 2015-E (GTIN-14: 008
• 00859105006109: Contains the following products Propeller Sensor Model 2014-D (GS1 GTIN-12: 00865528000037) Qual
• 00859105006093: Convenience Kit Contains the following products: Propeller Sensor Model 2014-R (GTIN-14: 0086552
• 00859105006086: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 0086552
• 00859105006079: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 0086552
• 00859105006062: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 0086552
• 00859105006055: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 0086552
• 00859105006048: The convenience kit contains the following products: 2 x Propeller Sensor Model II (GTIN-14: 008
• 00859105006031: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 0086552
• 00859105006024: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 0086552
• 00859105006017: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 0086552
• 00859105006000: The convenience kit contains the following products: 2 x Propeller Sensor Model II (GTIN-14: 008
• 00859105006345: The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory devi