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 Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.2
In Commercial Distribution

  • 00866489000098 ()
741743

  • Nucleic acid sample preparation instrument IVD, semi-automated
Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI.
Zoll Medical Corporation
8700-010001-01
In Commercial Distribution

  • 00847946021870 ()


  • Electrocardiography telemetric monitoring system
Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI.
Zoll Medical Corporation
8000-000619
In Commercial Distribution

  • 00847946021863 ()


  • Electrocardiography telemetric monitoring system
Blood Glucose Plus Blood Pressure Monitoring System
FORA CARE INC.
D40 Pro
In Commercial Distribution

  • 00816042012846 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
  • Home-use/point-of-care glucose analyser IVD, battery-powered
Blood Glucose Plus Blood Pressure Monitoring System
FORA CARE INC.
D40g
In Commercial Distribution

  • 00816042012044 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
  • Home-use/point-of-care glucose analyser IVD, battery-powered
The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
Coala-Life AB
201
In Commercial Distribution

  • 27350002700123 ()
  • 07350002700105 ()
  • 17350002700119 ()
N/A

  • Phonocardiograph
  • Electrocardiograph, home-use
STAND,INPUT BOX/PHOTIC EEG-1200
NIHON KOHDEN AMERICA, INC.
KC-001A
In Commercial Distribution

  • 00841983100857 ()
KC-001A

  • Instrument trolley
STAND,INPUT BOX/PHOTIC EEG-1200
NIHON KOHDEN CORPORATION
KC-001A
In Commercial Distribution

  • 04931921112830 ()
KC-001A

  • Instrument trolley
Cart (Stand), used with Electrode junction box or Flash lamp assembly
NIHON KOHDEN CORPORATION
KC-001A-01
In Commercial Distribution

  • 04931921007693 ()
KC-001A-01

  • Instrument trolley
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001120 ()
500-0001-12

  • Multiple vital physiological parameter monitoring system, clinical
  • Multiple-patient intensive/general healthcare physiologic monitoring system
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