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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Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.for eCommerce
Prodigy Diabetes Care, LLC
010500
In Commercial Distribution

  • 00384840105003 ()
  • 00384841104005 ()
  • 00384844105009 ()
  • 3 84840 10500 ()
010500

  • Glucose monitoring system IVD, home-use
Prodigy AutoCode Blood Glucose Monitoring System
Prodigy Diabetes Care, LLC
074300
In Commercial Distribution

  • 00384841518505 ()
  • 00384843743004 ()
  • 00384840743007 ()
  • 08484-0743-00 ()
074300

  • Glucose monitoring system IVD, home-use
PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
Prodigy Diabetes Care, LLC
051775
In Commercial Distribution

  • 00384840517752 ()
  • 30384840517753 ()
  • 08484-0517-75 ()
051775

  • Glucose monitoring system IVD, point-of-care
1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)
Prodigy Diabetes Care, LLC
010400
In Commercial Distribution

  • 00384843104003 ()
  • 00384840104006 ()
  • 00384844104002 ()
  • 3 84840 10400 ()
010400

  • Glucose IVD, kit, electrometry
24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.
SMD Manufacturing LLC
RP-MKITQ4-1
In Commercial Distribution

  • 10850001175217 ()
  • 00850001175210 ()
  • 73573-155-14 ()


  • Oral care kit, single-use
  • Basic manual toothbrush
  • Dental tooth-cleaning solution
  • Oral care swab
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
Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
Unistrip Technologies, LLC
038600
In Commercial Distribution

  • 00681131304863 ()
  • 00681131104869 ()
  • 90681131104862 ()
  • 30681131104860 ()
  • 10681131104866 ()
  • 49035-0386-00 ()
038600

  • Glucose IVD, kit, electrometry
ReliOn Ultima Blood Glucose Test Strips
WAL-MART STORES, INC.
70122
In Commercial Distribution

  • 30681131060319 ()
  • 00681131060318 ()
  • 66004-6031-5 ()
  • 10681131060315 ()
70122

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Relion Ultima Blood Glucose Test Strips
WAL-MART STORES, INC.
70121
In Commercial Distribution

  • 30681131060302 ()
  • 00681131060301 ()
  • 66004-6030-4 ()
  • 10681131060308 ()
70121

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
ReliOn Ultima Blood Glucose Test Strips
WAL-MART STORES, INC.
70973
In Commercial Distribution

  • 30681131060296 ()
  • 00681131060295 ()
  • 66004-6029-9 ()
  • 10681131060292 ()
70973

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