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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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Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; Brazil power cord; Z200+ thermal printer, (includes 2 starter packs of full-grid paper - 8"), Q-Stress premium transport cart with base, keyboard tray, storage shelf, large
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355277 ()
QS-6EA-ECDXA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; Brazil power cord; Z200+ thermal printer, (includes starter pack of full-grid paper - A4), XScribe premium transport cart with base, keyboard tray, storage shelf, large stor
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355208 ()
XSCRIBE-6AA-EGAXB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output and TM55 110V Treadmill; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer, (includes 2 starter packs of full-grid paper - 8"), Q-Stress premium transport cart with base, keyboard tr
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094354584 ()
QS6-ATTA1

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; UK power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; R
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094353587 ()
QS-6FA-CEDXA

  • Cardiopulmonary stress exercise monitoring system computer
Includes 1 Evolution Handle, FootMat Software for Clinicians CD with Huge-Mat Map, Help File and PDF of System Manual, MatScan XL 5400N Sensor installed in floor display, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan XL System
In Commercial Distribution

  • B970MXLE10 ()
MXLE1

  • Body-surface pressure mapping system
Includes MobileMat 3140 Sensor installed in floor display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, SportsAT Software CD with 3140 Map, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat Platform with SportsAT Software
In Commercial Distribution

  • B970MMATSPORTS0 ()
MMat-SPORTS

  • Body-surface pressure mapping system
Includes 1 MatScan 3150 Sensor installed in floor display with 1 Evolution Handle, SportsAT CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan Evolution Platform with SportsAT Software
In Commercial Distribution

  • B970ME1SPORTS0 ()
ME1-SPORTS

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, CONFORMat Clinical Software CD with 5330, 5331, and 5330_5331 Maps, (1) 5330-5 and (1) 5331-5 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, 1 Web-based Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 System with Clinical Software
In Commercial Distribution

  • B970CEC5330533120 ()
CEC5330-5331-2

  • Body-surface pressure mapping system
PCE-210 PC-Based Exercise Stress System (treadmill, no computer); 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection, treadmill, stress belt, stress electrodes and manuals on CD)
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094088595 ()
CPSP-UN-UC-D-T

  • Electrocardiograph, professional, multichannel
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Resting-ECG Measurement and MEANS Analysis ECG Measurements & Expert System, The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I3
In Commercial Distribution

  • 07290110255411 ()
HASP-SW-K-I3-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
  • Patient-administration information system application software
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