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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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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
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
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S1
In Commercial Distribution

  • 07290110252762 ()
HASP-SW-K-S1-01

  • Cardiopulmonary stress exercise monitoring system computer
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Spanish language and CD manual; AHA 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264364 ()
H3PLUS-CBA-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Spanish language and CD manual; IEC 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264357 ()
H3PLUS-CBB-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Spanish language and CD manual; AHA 5 wire, 15 in. (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264340 ()
H3PLUS-CBD-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); French language and CD manual; IEC 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264326 ()
H3PLUS-CCB-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); French language and CD manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264319 ()
H3PLUS-CCE-XXXXX

  • Electrocardiographic ambulatory recorder
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