DEVICE: Propeller (00865528000099)
Device Identifier (DI) Information
Propeller
Sensor Model 2017-B
In Commercial Distribution
RECIPROCAL LABS CORPORATION
Sensor Model 2017-B
In Commercial Distribution
RECIPROCAL LABS CORPORATION
Model 2017-B. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for Neohaler® 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.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
No | |
Yes | |
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No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61866 | Inhaler dose sensor |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CAF | Nebulizer (Direct Patient Interface) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K180770 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
db85798a-437e-4cd6-abf3-8dcd53dc71aa
October 12, 2018
1
September 11, 2018
October 12, 2018
1
September 11, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined