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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Propeller System includes the Propeller SMI Model 2014-R 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 SMI 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 SMI 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 SMI, 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 SMI technique. When used under the care of a physician with a prescribed SMI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to SMI 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-R
In Commercial Distribution

  • 00865528000020 ()


  • Inhaler dose sensor
The Propeller System includes the Propeller MDI Model 2 OTC 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 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
MDI 2 Sensor
In Commercial Distribution

  • 00865528000013 ()


  • Inhaler dose sensor
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-35P 3.5 fr. 32cm Polyurethane
In Commercial Distribution

  • 10865506000285 ()
  • 00865506000288 ()


  • Arterial blood sampling kit
  • Intravenous line stopcock
  • Umbilical catheter
  • Split-septum needleless valve-connector
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-50P 5.0 fr. 32cm Polyurethane
In Commercial Distribution

  • 10865506000278 ()
  • 00865506000271 ()


  • Split-septum needleless valve-connector
  • Umbilical catheter
  • Intravenous line stopcock
  • Arterial blood sampling kit
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-50S 5.0 fr. 32cm Silicone
In Commercial Distribution

  • 10865506000261 ()
  • 00865506000264 ()


  • Split-septum needleless valve-connector
  • Umbilical catheter
  • Intravenous line stopcock
  • Arterial blood sampling kit
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-43P 4.3 fr. 32cm Polyurethane
In Commercial Distribution

  • 10865506000254 ()
  • 00865506000257 ()


  • Arterial blood sampling kit
  • Intravenous line stopcock
  • Umbilical catheter
  • Split-septum needleless valve-connector
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-35S 3.5 fr. 32cm Silicone
In Commercial Distribution

  • 10865506000230 ()
  • 00865506000233 ()


  • Split-septum needleless valve-connector
  • Umbilical catheter
  • Intravenous line stopcock
  • Arterial blood sampling kit
Single lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood Transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valves.
HUMMINGBIRD MED DEVICES INC
UAC-HM-25P 2.5 fr. 25cm Polyurethane
In Commercial Distribution

  • 10865506000223 ()
  • 00865506000226 ()


  • Split-septum needleless valve-connector
  • Umbilical catheter
  • Intravenous line stopcock
  • Arterial blood sampling kit
Hydraulic Stretcher, two tone color Blue and Gray base. Stretcher includes O2 tank, IV Pole,
SETMARK INC.
TR-102
In Commercial Distribution

  • 00865388000468 ()


  • Hospital stretcher, manual
Surgical Laser Fiber 200 micron series, silicone, blue tefzel, NA 0.22, damage resistant SMA905, single use, blue extension sleeves, EO sterile, Flat Tip, MF label
MED -FIBERS INC.
MF-200-SBT
In Commercial Distribution

  • 00865325000179 ()


  • General/multiple surgical laser system beam guide, reusable
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