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Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
roflufocon E
In Commercial Distribution
- 00865576000218 ()
roflufocon E
- Rigid-gas-permeable corrective contact lens, daily-wear
Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
roflufocon D
In Commercial Distribution
- 00865576000201 ()
roflufocon D
- Rigid-gas-permeable corrective contact lens, daily-wear
No Description
WESTRIDGE LABORATORIES INCORPORATED
SportLube 3.4 fl oz Silicone Based
In Commercial Distribution
- 40865542000349 ()
- 00865542000341 ()
- Sexual lubricant
No Description
WESTRIDGE LABORATORIES INCORPORATED
Sport Lube 8.1 fl oz Silicone Bottle
In Commercial Distribution
- 00865542000303 ()
- 30865542000304 ()
- Sexual lubricant
A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution
- 00865536000234 ()
- Neonatal/paediatric heart rate monitoring application software
- Neonatal/paediatric heart rate monitoring hardware
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.
RECIPROCAL LABS CORPORATION
Sensor Model 2017-B
In Commercial Distribution
- 00865528000099 ()
- Inhaler dose sensor
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
Sensor Model 2016-M-L
In Commercial Distribution
- 00865528000082 ()
- Inhaler dose sensor
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
Sensor Model 2016-M-S
In Commercial Distribution
- 00865528000075 ()
- Inhaler dose sensor
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
Sensor Model 2015-E
In Commercial Distribution
- 00865528000068 ()
- Inhaler dose sensor
The Propeller System includes the Propeller DPI Model 2014-D 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 DPI 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 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 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 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.
When used under the care of a physician with a prescribed DPI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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
Sensor Model 2014-D
In Commercial Distribution
- 00865528000037 ()
- Inhaler dose sensor