Propeller

GUDID 00865528000068

The Propeller System includes the Propeller Sensor Model 2015-E. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Ellipta devices. 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 DPI 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 DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. When used with a prescribed DPI, 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 DPI technique. 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 DPI medication(s) by a participant. The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.

RECIPROCAL LABS CORPORATION

Inhaler dose sensor

• Primary Device ID: 00865528000068
• NIH Device Record Key: e145faca-4c8b-4cc8-acf9-f42249e8d460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Propeller
• Version Model Number: Sensor Model 2015-E
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865528000068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161454

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: 2017-01-16

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