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 5 High Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 2 Strideway Power Supply, 2 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3164 Sensor Map, 2 Strideway Shipping Cases, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only)
Tekscan, Inc.
5-Tile High Resolution Strideway System
In Commercial Distribution

  • B970HRSW50 ()
HRSW5

  • Body-surface pressure mapping system
Includes 4 High Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 1 Strideway Power Supply, 1 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3164 Sensor Map, Strideway Shipping Case, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only)
Tekscan, Inc.
4-Tile High Resolution Strideway System
In Commercial Distribution

  • B970HRSW40 ()
HRSW4

  • Body-surface pressure mapping system
Includes 3 High Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 1 Strideway Power Supply, 1 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3164 Sensor Map, Strideway Shipping Case, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only)
Tekscan, Inc.
3-Tile High Resolution Strideway System
In Commercial Distribution

  • B970HRSW30 ()
HRSW3

  • Body-surface pressure mapping system
Includes 2 High Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 1 Strideway Power Supply, 1 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3164 Sensor Map, Strideway Shipping Case, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only)
Tekscan, Inc.
2-Tile High Resolution Strideway System
In Commercial Distribution

  • B970HRSW20 ()
HRSW2

  • Body-surface pressure mapping system
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File and PDF of System Manual, 6 F-Scan 3000E Sensors, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Web-Based Training Session.
Tekscan, Inc.
F-Scan Lite VersaTek System
In Commercial Distribution

  • B970FVL10 ()
FVL1

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330E Sensors, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek System
In Commercial Distribution

  • B970CCV20 ()
CCV2

  • Body-surface pressure mapping system
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); AHA 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263169 ()
RSCRIBE-6AC-AXDBB

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Snap adapters (set of 10) and monitoring electrodes (pouch of 10); AHA 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263138 ()
RSCRIBE-6AC-XXBAB

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Snap adapters (set of 10) and monitoring electrodes (pouch of 10); 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

  • 00732094263084 ()
RSCRIBE-6CC-XXBAA

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); 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
Not in Commercial Distribution

  • 00732094262964 ()
RSCRIBE-7AC-XXABA

  • Electrocardiograph, professional, multichannel
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