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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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Defibrillator/Pacer Analyzer
FLUKE ELECTRONICS CORPORATION
IMPULSE4K-USA120V
In Commercial Distribution

  • 00850540007133 ()
2247157

  • External defibrillator tester
Defibrillator Analyzer
FLUKE ELECTRONICS CORPORATION
IMPULSE 6000D
In Commercial Distribution

  • 00850540007119 ()
2811928

  • External defibrillator tester
The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument for testing defibrillators and external (Transcutaneous) Pacemakers. It combines the complete testing functions of a Defibrillator Tester, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator into one compact, lightweight, and easy-to-use instrument. The Delta 3300 tests all Defibrillators including AEDs. It measures both monophasic and Bi-Phasic waveforms. It is compact, lightweight and easy to use. The test results can be saved in the internal memory and uploaded to the PC and printed using ProComPrint software (CD included with the unit).
NETECH CORPORATION
DELTA 3300
In Commercial Distribution

  • B3356600 ()
660

  • External defibrillator tester
Delta 3000 is a full function defibrillator analyzer including Transcutaneous Pacemakers. In addition to the capability of testing all bi-polar defibrillators, it tests all Transcutaneous pacers, Atrial and Ventricular pacemakers. Delta 3000 is compact, light weight and easy to use. Among the functions include energy, peak voltage as well as cardio version, 10 lead ECG Arrhythmia waveform. Test results can be easily uploaded to a PC through the serial port.
NETECH CORPORATION
Delta 3000
In Commercial Distribution

  • B3356500 ()
650

  • External defibrillator tester
Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators. – tests Monophasic, Biphasic and Pulsed Multiphasic Defibrillators, AEDs and Transcutaneous Pacers – see www.datrend.com for complete information
Datrend Systems Inc
Phase3
In Commercial Distribution

  • B418PHASE380004400 ()
8000-440

  • External defibrillator tester
Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Wearable Antenna Assembly/StimQ Wearable Antenna Gear
STIMWAVE TECHNOLOGIES INCORPORATED
PDBT-915-2K
In Commercial Distribution

  • 00818225020822 ()


  • Multiple active implantable device programmer
  • Implantable spinal cord electrical stimulation system programmer
Wearable Antenna Assembly/StimQ Wearable Antenna Gear
STIMWAVE TECHNOLOGIES INCORPORATED
PDBT-915-2K
In Commercial Distribution

  • 00818225020150 ()


  • Implantable spinal cord electrical stimulation system programmer
  • Multiple active implantable device programmer
The illumigene Mycoplasma External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Mycoplasma test kit. External controls are used as part of a routine quality control program. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279940
Not in Commercial Distribution

  • 00840733101144 ()
279940

  • Mycoplasma pneumoniae nucleic acid IVD, control
Hemostatic Granules. For minor external bleeding from wounds and procedures the device is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. For moderate to severe external bleeding wounds the device is indicated for temporary external treatment for controlling moderate to severe bleeding.
MEDTRADE PRODUCTS LIMITED
FG07730591
In Commercial Distribution

  • 15060206630588 ()
  • 35060206630582 ()
  • 75060206630580 ()

  • Weight: 3 Gram
FG07730591

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
POLYTECHNIC RESOURCES INC
M100780EL
In Commercial Distribution

  • B446100780EL0 ()
  • B446M100780EL1 ()

  • Outer Diameter: 34.3 Millimeter


  • Vascular graft extraluminal mesh-sleeve, coronary
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