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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 ASSURE Wearable Cardioverter Defibrillator System
Kestra Medical Technologies, Inc.
80014-002
In Commercial Distribution

80014-002

  • Wearable defibrillation system defibrillator
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-004
In Commercial Distribution

80008-004

  • Wearable defibrillation system defibrillator
The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-007
In Commercial Distribution

  • 00840241600184 ()

  • Style B, Size 7
80016-007

  • Wearable defibrillation system defibrillator
A rechargeable battery that powers the ASSURE System
Kestra Medical Technologies, Inc.
3322882-005
In Commercial Distribution

  • 00840241600009 ()
3322882-005

  • Wearable defibrillation system defibrillator
The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution

  • 00840733101434 ()
  • 00840733101441 ()
8209

  • Helicobacter pylori urease IVD, kit, chromogenic
No Description
Thoratec Corporation
20099-2575-001
In Commercial Distribution

  • 00813024013105 ()
20099-2575-001

  • Vascular graft tunneller
No Description
Thoratec Corporation
20010-0000-090
In Commercial Distribution

  • 00813024012689 ()
20010-0000-090

  • Electrical-only medical device connection cable, reusable
No Description
Thoratec Corporation
20010-0000-111
In Commercial Distribution

  • 00813024012665 ()
20010-0000-111

  • Electrical-only medical device connection cable, reusable
No Description
Thoratec Corporation
104911Y
In Commercial Distribution

  • 00813024011651 ()
104911Y

  • Implantable ventricular circulatory assist system
No Description
Thoratec Corporation
106015Y
In Commercial Distribution

  • 00813024011644 ()
106015Y

  • Implantable ventricular circulatory assist system
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