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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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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 and RScribe with Interpretation; Turnkey system with configured CPU, no display; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirection
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259315 ()
XSCRIBE-6EB-DEBAB

  • 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 and RScribe with Interpretation; Software kit; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259308 ()
XSCRIBE-6EC-DDBAB

  • 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 and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer, (includes starter pack of full-grid paper - 8"), XScribe premium transport cart with base, keyboard tray, storage shelf, large
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259247 ()
XSCRIBE-6ED-AFAAX

  • Electrocardiographic lead set, reusable
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 and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; I
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259230 ()
XSCRIBE-6ED-DDBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer, (includes starter pack of full-grid paper - A4), XScribe premium transport cart with base, keyboard tray, storage shelf, la
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259209 ()
XSCRIBE-6FD-DGBAA

  • 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 and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Iso
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259094 ()
XSCRIBE-6GD-DDBAX

  • 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
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