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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 4 VersaTek Cuffs, 2 VersaTek 2-Port Hubs, 2 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101D Map with 3 Equilibration Files, Help File and PDF of System Manual, 2 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 2 VersaTek System
In Commercial Distribution

  • B970HRV20 ()
HRV2

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
HR Mat VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970HRV10 ()
HRV1

  • Body-surface pressure mapping system
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); AHA 10 wire, 12-lead lead set with medi-clip ends; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094319033 ()
RSCRIBE-6BC-XXACA

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Brazil INMETRO labeling; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094262988 ()
RSCRIBE-6GC-XXCBA

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Brazil INMETRO labeling; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094262995 ()
RSCRIBE-6GC-XXCAA

  • Electrocardiograph, professional, multichannel
No Description
Lonza Verviers
BE12-771P20
In Commercial Distribution

  • 05407010120219 ()


  • Cell culture medium IVD
No Description
Lonza Verviers
BE12-771P10
In Commercial Distribution

  • 05407010120202 ()


  • Cell culture medium IVD
Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuff Cables, 2 built in VersaTek Cuffs, FootMat Software for Researchers CD with 7101E Map, Help File and PDF of System Manual, MobileMat HR 7101E Sensor installed in the MobileMat floor display, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat HR Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970MMATHRRES0 ()
MMatHR-RES

  • Body-surface pressure mapping system
Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuff Cables, 2 built-in VersaTek Cuffs, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, MobileMat HR 7101E Sensor installed in the MobileMat floor display, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat HR Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970MMATHRCLINICAL0 ()
MMatHR-CLINICAL

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Researchers CD with 7101E Sensor Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
HR Mat VersaTek Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970HRV1RES0 ()
HRV1-RES

  • Body-surface pressure mapping system
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