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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 Class Implantable

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reSET® Mobile App, Android - 10851580008095

reSET® Mobile Application running on Android. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: - increase abstinence from a patient’s substances of abuse during treatment, and - increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008095 ()


  • Mental health/function therapeutic software, screen-viewed

Eversense 365 Mobile Application (Android) - 00817491024275

Eversense 365 Mobile Application for Android is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5504-06-300
In Commercial Distribution

  • 00817491024275 ()
FG-5504-06-300

  • Implantable glucose monitoring system

Eversense® Mobile App Android - 00817491023612

Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution

  • 00817491023612 ()
FG-5502-01-300

  • Implantable glucose monitoring system

Eversense NOW Mobile App Android - 00817491023490

The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution

  • 00817491023490 ()
FG-5902-01-300

  • Implantable glucose monitoring system

Eversense® Mobile App Android - 00817491022387

Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution

  • 00817491022387 ()
FG-5502-01-300

  • Implantable glucose monitoring system

Eversense® Mobile App Android - 00817491020826

Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution

  • 00817491020826 ()
FG-5600-01-300

  • Implantable glucose monitoring system

Sonify Hearing - 00850049194020

An Android mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-07
In Commercial Distribution

  • 00850049194020 ()


  • Air-conduction hearing aid, receiver-in-canal

Amplion Care Assurance - 00850016398741

Amplion phone application for the Android OS system used on smartphones, Version 2.4.0
AMPLION CLINICAL COMMUNICATIONS, INC.
S-APP-240-1
Not in Commercial Distribution

  • 00850016398741 ()
S-APP-240-1

  • Nurse call system

Amplion Care Assurance - 00850016398338

Amplion phone application for the Android OS system used on smartphones, Version 2.3.8
AMPLION CLINICAL COMMUNICATIONS, INC.
S-APP-238-1
Not in Commercial Distribution

  • 00850016398338 ()
S-APP-238-1

  • Nurse call system

Bosma Enterprises - 00818634020383

Accelerate-OR CIN Kit; Each Kit Includes QuickSuite Kit, 20x29 Disposable Pillowcase (2), 4x60 Foam Positioning Strap and Disposable Microfiber Mop Head (2).
Bosma Enterprises
10-8020CIN
In Commercial Distribution

  • 10818634020380 ()
  • 00818634020383 ()
10-8020CIN

  • Operating room turnover kit
  • Surgical linen/cushion set
  • Limb/torso/head restraint, single-use
  • Basic pillowcase, single-use

Fertile Window - 06430060159983

No Description
Ouraring Inc.
Fertile Window Android
In Commercial Distribution

  • 06430060159983 ()


  • Menstrual cycle self-monitoring software

EpiMonitor - 00853858006386

No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system

myBETAapp - 05713495000060

No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software

Care Assist - 00884838127449

Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist Android
In Commercial Distribution

  • 00884838127449 ()
989803221541

  • Centralized patient monitor

myDigitalKnee® - 09413000126273

myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor

DIGITIVA Mobile Application - 00304692416447

Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Android devices.
Astellas Pharma Us, Inc.
Android (Version 1)
In Commercial Distribution

  • 00304692416447 ()
DIGI-002

  • Medication reminder application software

actiTENS - B786SBM2AA1100

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system

N/A - 00816576025411

CIN Agar, 15x100 monoplate, 10/pk (Cefsulodin, Irgasan, Novobiocin) For the selective isolation of Yersinia enterocolitica and Aeromonas spp. Inoculate at room temperature.
HARDY DIAGNOSTICS
G220
Not in Commercial Distribution

  • 00816576025404 ()
  • 00816576025411 ()
G220

  • Differential/selective agar culture medium IVD

Kontron - 06946725554357

Datascope Trio Compatible Oximax Direct Connect Ear Clip Sensor
APK Technology Co.,Ltd.
10306
In Commercial Distribution

  • 06946725554357 ()


  • Tissue saturation oximeter sensor, reprocessed

Nihon Kohden - 06946725538869

Compatible with GE, 3 Lead Grouped ECG lead wires,Pinch,AHA
APK Technology Co.,Ltd.
A3157-EL1-001
In Commercial Distribution

  • 06946725538869 ()


  • Electrocardiographic lead set, reusable

Philips - 06946725529072

Temperature Adaptter Cable
APK Technology Co.,Ltd.
DHP-30-AD0
Not in Commercial Distribution

  • 06946725529072 ()


  • Electrocardiographic lead set, reusable

Mindray - 06946725529034

Mindray Pano-Philips 3L ECG Adapter
APK Technology Co.,Ltd.
A-CO-182
In Commercial Distribution

  • 06946725529034 ()
  • 16946725590635 ()
  • 16946725590918 ()


  • Electrocardiographic lead set, reusable

Spacelabs - 06946725529010

Spacelabs Ultra-Philips 3L ECG Adapter
APK Technology Co.,Ltd.
A-CO-180
In Commercial Distribution

  • 06946725529010 ()
  • 16946725590611 ()
  • 16946725590895 ()


  • Electrocardiographic lead set, reusable

Mindray - 06946725528686

No Description
APK Technology Co.,Ltd.
MDR-009-004782-00
In Commercial Distribution

  • 06946725528686 ()


  • Electrocardiographic lead set, reusable

Mindray - 06946725528679

No Description
APK Technology Co.,Ltd.
MDR-009-004786-00
In Commercial Distribution

  • 06946725528679 ()


  • Electrocardiographic lead set, reusable

Philips - 06946725528648

No Description
APK Technology Co.,Ltd.
PH-989803171851
In Commercial Distribution

  • 06946725528648 ()


  • Electrocardiographic lead set, reusable

Mindray - 06946725528624

No Description
APK Technology Co.,Ltd.
MDR-009-004786-00-DP
In Commercial Distribution

  • 06946725528624 ()


  • Electrocardiographic lead set, reusable

Mindray - 06946725528600

No Description
APK Technology Co.,Ltd.
MDR-009-004786-00
In Commercial Distribution

  • 06946725528600 ()


  • Electrocardiographic lead set, reusable

Nihon Kohden - 06946725528556

No Description
APK Technology Co.,Ltd.
NK-BR-906PA-DP
In Commercial Distribution

  • 06946725528556 ()


  • Electrocardiographic lead set, reusable

Nihon Kohden - 06946725528549

No Description
APK Technology Co.,Ltd.
NK-BR-916PA-DP
In Commercial Distribution

  • 06946725528549 ()


  • Electrocardiographic lead set, reusable

Din ECG - 06946725528273

No Description
APK Technology Co.,Ltd.
DLS-DIN-24
In Commercial Distribution

  • 06946725528273 ()


  • Electrocardiographic lead set, reusable

Nihon Kohden - 06946725528266

No Description
APK Technology Co.,Ltd.
NK-BR-913PA-DP
In Commercial Distribution

  • 06946725528266 ()


  • Electrocardiographic lead set, reusable

Reusable ECG Lead Wires for GE - 06946725528105

No Description
APK Technology Co.,Ltd.
10352
In Commercial Distribution

  • 06946725528105 ()


  • Electrocardiographic lead set, reusable

Spacelabs - 06946725527993

6946725527993
APK Technology Co.,Ltd.
A1902-C02
In Commercial Distribution

  • 06946725527993 ()


  • Electrocardiographic lead set, reusable

Spacelabs - 06946725527306

No Description
APK Technology Co.,Ltd.
A0006D05-001
In Commercial Distribution

  • 06946725527306 ()


  • Electrocardiographic lead set, reusable

Spacelabs - 06946725527290

No Description
APK Technology Co.,Ltd.
A0006D05
In Commercial Distribution

  • 06946725527290 ()


  • Electrocardiographic lead set, reusable

Spacelabs - 06946725527283

No Description
APK Technology Co.,Ltd.
A0006D03-001
In Commercial Distribution

  • 06946725527283 ()


  • Electrocardiographic lead set, reusable

Spacelabs - 06946725527276

No Description
APK Technology Co.,Ltd.
A0006D03
In Commercial Distribution

  • 06946725527276 ()


  • Electrocardiographic lead set, reusable

Drager - 06946725527269

No Description
APK Technology Co.,Ltd.
A0005D06-001
In Commercial Distribution

  • 06946725527269 ()


  • Electrocardiographic lead set, reusable

Drager - 06946725527252

No Description
APK Technology Co.,Ltd.
A0005D06
In Commercial Distribution

  • 06946725527252 ()


  • Electrocardiographic lead set, reusable
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