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ST. JUDE MEDICAL, INC.
1014937
In Commercial Distribution
- 05415067036629 ()
1014937
- Coronary optical coherence tomography system
Tableside Controller Next
ST. JUDE MEDICAL, INC.
1014936
In Commercial Distribution
- 05415067033680 ()
1014936
- Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1014666
In Commercial Distribution
- 05415067030856 ()
1014666
- Coronary optical coherence tomography system
Cable
ST. JUDE MEDICAL, INC.
C12978
In Commercial Distribution
- 05415067027764 ()
C12978
- Coronary optical coherence tomography system
DIGITAL WRIST BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2910W
In Commercial Distribution
- 00869378000445 ()
- Patient monitoring system module, blood pressure, noninvasive
DIGITAL ARM BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2704A
In Commercial Distribution
- 00869378000438 ()
- Patient monitoring system module, blood pressure, noninvasive
Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution
- 00857335005121 ()
- 57335-0005-12 ()
57335000512
- Mental health/function therapeutic software, screen-viewed
NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.
The device is designed for children greater than five years of age, adolescent and adult subjects.
SAFEY MEDICAL DEVICES PRIVATE LIMITED
165253
In Commercial Distribution
- 00860013746407 ()
- Weight: 300 Gram
- Expiratory peak flow meter, digital
BT-001 (AspyreRx) is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to treat patients 18 years or older with type 2 diabetes.
Better Therapeutics, Inc.
ma.1.0.0
In Commercial Distribution
- 00860011146704 ()
- Mental health/function therapeutic software, screen-viewed
A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to reinforce their skills in acceptance and commitment therapy.
Swing Therapeutics, Inc.
1.2
In Commercial Distribution
- 00860010446324 ()
- Mental health/function therapeutic software, screen-viewed