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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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Bruno - 00866457000372

Ketone Test Strips
BRUNO PHARMA INNOVATIONS, LLC
MD6
In Commercial Distribution

  • 00866457000372 ()
  • 80816042013023 ()


  • Multiple clinical chemistry analyte monitoring system IVD, home-use

ST Temporalis - 00866453000147

Silicone Temporal Implant - Large
Osteosymbionics, LLC
STT-60
In Commercial Distribution

  • 00866453000147 ()


  • Chin prosthesis

ST Temporalis - 00866453000130

Silicone Temporal Implant - Small
Osteosymbionics, LLC
STT-50
In Commercial Distribution

  • 00866453000130 ()


  • Chin prosthesis

Cystosure - 00866403000210

16Fr Cystosure Plus, 16Fr, silicone catheter
EMMY MEDICAL LLC
10-400
In Commercial Distribution

  • 00866403000210 ()
  • 10866403000217 ()
  • 20866403000214 ()

  • Catheter Gauge: 16 French


  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Cystosure - 00866403000203

Cystosure XL, 16 Fr, silicone catheter
EMMY MEDICAL LLC
10-600
In Commercial Distribution

  • 00866403000203 ()
  • 10866403000200 ()
  • 20866403000207 ()

  • Catheter Gauge: 16 French


  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Radlink GPS Bucky Cart - 00866389000136

The Radlink GPS Bucky Cart is a manually operated cart with one compartment that is meant for housing and transporting flat panel detectors.
RADLINK, INC.
Bucky
In Commercial Distribution

  • 00866389000136 ()


  • X-ray film cassette holder

Filtro de Endotoxina Nephros EndoPur (plano) 20" - 00866318000398

Intended Use: The Filtro de Endotoxina Nephros EndoPur (plano) 20" is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0120P
In Commercial Distribution

  • 00866318000398 ()
  • 10866318000395 ()
  • 20866318000392 ()


  • Microbial water purification filter, non-sterilizable

Nephros EndoPur Endotoxin 10” Filter - 00866318000381

Intended Use: The Nephros EndoPur Endotoxin 10” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110H
In Commercial Distribution

  • 10866318000388 ()
  • 00866318000381 ()
  • 20866318000385 ()


  • Microbial water purification filter, non-sterilizable

EndoPur Endotoxin 20" Filter - 00866318000374

Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0120
Not in Commercial Distribution

  • 20866318000378 ()
  • 00866318000374 ()
  • 10866318000371 ()


  • Microbial water purification filter, non-sterilizable

EndoPur Endotoxin 10" Filter Fin - 00866318000367

Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Fin is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110F
Not in Commercial Distribution

  • 20866318000361 ()
  • 10866318000364 ()
  • 00866318000367 ()


  • Microbial water purification filter, non-sterilizable

EndoPur Endotoxin 10" Filter - 00866318000350

Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110
Not in Commercial Distribution

  • 20866318000354 ()
  • 10866318000357 ()
  • 00866318000350 ()


  • Microbial water purification filter, non-sterilizable

Filtro de Endotoxina Nephros EndoPur (plano) 10" - 00866318000312

Intended Use: The Filtro de Endotoxina Nephros EndoPur (plano) 10" is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110P
In Commercial Distribution

  • 00866318000312 ()
  • 10866318000319 ()
  • 20866318000316 ()


  • Microbial water purification filter, non-sterilizable

SSUmini JG 3/8 - 00866318000305

The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0251C
Not in Commercial Distribution

  • 10866318000302 ()
  • 00866318000305 ()


  • Microbial water purification filter, non-sterilizable

Large Fragment Active Plating System - 00866204000266

5mm Locking Screw, 34mm
Incipio Devices
00-505-000-34
Not in Commercial Distribution

  • 00866204000266 ()


  • Hip internal fixation system

Large Fragment Active Plating System - 00866204000259

5mm Locking Screw, 30mm
Incipio Devices
00-505-000-30
Not in Commercial Distribution

  • 00866204000259 ()


  • Hip internal fixation system

Large Fragment Active Plating System - 00866204000242

5mm Locking Screw, 28mm
Incipio Devices
00-505-000-28
Not in Commercial Distribution

  • 00866204000242 ()


  • Hip internal fixation system

Large Fragment Active Plating System - 00866204000235

5mm Locking Screw, 26mm
Incipio Devices
00-505-000-26
Not in Commercial Distribution

  • 00866204000235 ()


  • Hip internal fixation system

Large Fragment Active Plating System - 00866204000228

5mm Locking Screw, 24mm
Incipio Devices
00-505-000-24
Not in Commercial Distribution

  • 00866204000228 ()


  • Hip internal fixation system

Large Fragment Active Plating System - 00866204000211

Large fragment plate, 9 hole, 205 mm
Incipio Devices
00-505-050-09
Not in Commercial Distribution

  • 00866204000211 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Large Fragment Active Plating System - 00866204000204

Large fragment plate, 7 hole, 165 mm
Incipio Devices
00-505-050-07
Not in Commercial Distribution

  • 00866204000204 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

The Fitness Family - 00866066000305

A digital thermometer designed to measure body temperature orally, rectally or under the arm. It has a silicon & plastic structure, a metal sensing tip and a battery-powered chip and LCD screen. It is for multiple uses.
GMB INTERNATIONAL LIMITED
001
Not in Commercial Distribution

  • 00866066000305 ()


  • Thermometer kit

Precision Disposable Products - 00865773000370

ECG Electrodes Case - Teardrop
PRECISION DISPOSABLE PRODUCTS INC
SF05
Not in Commercial Distribution

  • 00865773000370 ()
  • 00865773000387 ()


  • Nitrogen terminal unit

Precision Disposable Products - 00865773000363

ECG Electrodes Case - Teardrop
PRECISION DISPOSABLE PRODUCTS INC
SF05
Not in Commercial Distribution

  • 00865773000363 ()
  • 00865773000387 ()


  • Nitrogen terminal unit

Precision Disposable Products - 00865773000349

ECG Electrodes Case - Square
PRECISION DISPOSABLE PRODUCTS INC
SF22
Not in Commercial Distribution

  • 00865773000349 ()
  • 00865773000356 ()


  • Nitrogen terminal unit

Precision Disposable Products - 00865773000332

ECG Electrodes Case - Square
PRECISION DISPOSABLE PRODUCTS INC
SF22
Not in Commercial Distribution

  • 00865773000332 ()
  • 00865773000356 ()


  • Nitrogen terminal unit

Precision Disposable Products - 00865773000318

ECG Electrodes Bag - Circle
PRECISION DISPOSABLE PRODUCTS INC
SF08
Not in Commercial Distribution

  • 00865773000318 ()
  • 00865773000325 ()


  • Nitrogen terminal unit

Precision Disposable Products - 00865773000301

ECG Electrodes Case - Circle
PRECISION DISPOSABLE PRODUCTS INC
SF08
Not in Commercial Distribution

  • 00865773000301 ()
  • 00865773000325 ()


  • Nitrogen terminal unit

EDG® Ortho 65mm - 00865707000445

EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 4mm offset depth gauge
EDGE SURGICAL, INC.
21342-65-01-40-LN
In Commercial Distribution

  • 10865707000442 ()
  • 00865707000445 ()

  • Length: 65 Millimeter
  • 4mm offset


  • Surgical depth gauge, single-use

EDG® Ortho 65mm - 00865707000438

EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 1mm offset depth gauge.
EDGE SURGICAL, INC.
21342-65-01-10-LN
In Commercial Distribution

  • 10865707000435 ()
  • 00865707000438 ()

  • Length: 65 Millimeter
  • 1mm offset


  • Surgical depth gauge, single-use

EDG® Ortho 65mm - 00865707000414

The EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriately length of screw in orthopedic procedures. This device comes sterile and ready to use once removed from its packaging.
EDGE SURGICAL, INC.
21342-65-01
Not in Commercial Distribution

  • 00865707000414 ()
  • 10865707000411 ()


  • Surgical depth gauge, single-use

Optimum Infinite - 00865576000294

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
Tisilfocon A
In Commercial Distribution

  • 00865576000294 ()
Tisilfocon A

  • Rigid-gas-permeable corrective contact lens, daily-wear

HEXA100 - 00865576000287

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
hexafocon A
In Commercial Distribution

  • 00865576000287 ()
hexafocon A

  • Rigid-gas-permeable corrective contact lens, daily-wear

Hybird FS - 00865576000270

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
hybufocon A
In Commercial Distribution

  • 00865576000270 ()
hybufocon A

  • Rigid-gas-permeable corrective contact lens, daily-wear

Optimum HR 1.53 - 00865576000256

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
hirafocon B
In Commercial Distribution

  • 00865576000256 ()
hirafocon B

  • Rigid-gas-permeable corrective contact lens, daily-wear

Optimum HR 1.51 - 00865576000249

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
hirafocon A
In Commercial Distribution

  • 00865576000249 ()
hirafocon A

  • Rigid-gas-permeable corrective contact lens, daily-wear

Optimum Classic - 00865576000232

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
roflufocon A
In Commercial Distribution

  • 00865576000232 ()
roflufocon A

  • Rigid-gas-permeable corrective contact lens, daily-wear

Optimum Comfort - 00865576000225

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
roflufocon C
In Commercial Distribution

  • 00865576000225 ()
roflufocon C

  • Rigid-gas-permeable corrective contact lens, daily-wear

Optimum Extreme - 00865576000218

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
roflufocon E
In Commercial Distribution

  • 00865576000218 ()
roflufocon E

  • Rigid-gas-permeable corrective contact lens, daily-wear

Optimum Extra - 00865576000201

Rigid Gas Permeable Contact Lens
CONTAMAC HOLDINGS LIMITED
roflufocon D
In Commercial Distribution

  • 00865576000201 ()
roflufocon D

  • Rigid-gas-permeable corrective contact lens, daily-wear

SportLube - 00865542000341

No Description
WESTRIDGE LABORATORIES INCORPORATED
SportLube 3.4 fl oz Silicone Based
In Commercial Distribution

  • 40865542000349 ()
  • 00865542000341 ()


  • Sexual lubricant

SportLube - 00865542000303

No Description
WESTRIDGE LABORATORIES INCORPORATED
Sport Lube 8.1 fl oz Silicone Bottle
In Commercial Distribution

  • 00865542000303 ()
  • 30865542000304 ()


  • Sexual lubricant

HeRO duet - 00865536000234

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

Propeller - 00865528000099

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

Propeller - 00865528000082

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

Propeller - 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
Sensor Model 2016-M-S
In Commercial Distribution

  • 00865528000075 ()


  • Inhaler dose sensor

Propeller - 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
Sensor Model 2015-E
In Commercial Distribution

  • 00865528000068 ()


  • Inhaler dose sensor

Propeller - 00865528000037

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

Propeller - 00865528000020

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

Propeller - 00865528000013

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

Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System - 00865506000288

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
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