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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RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; No patient cable; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
Not in Commercial Distribution

  • 00732094294101 ()
RSCRIBE-7EC-XXDXA

  • Electrocardiograph, professional, multichannel
Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101QL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (4) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 4 System
In Commercial Distribution

  • B970VH40 ()
VH4

  • Body-surface pressure mapping system
Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101TL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (3) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 3 System
In Commercial Distribution

  • B970VH30 ()
VH3

  • Body-surface pressure mapping system
Includes 8 Evolution Handles, (2) 4-Port Powered USB Hubs, BPMS Clinical Software CD with 5315O Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (8) 5315 Sensors with 1 Eight-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE8
In Commercial Distribution

  • B970BCE80 ()
BCE8

  • Body-surface pressure mapping system
Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, BPMS Clinical Software CD with 5315QL Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5315 Sensors with 1 Four-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE4
In Commercial Distribution

  • B970BCE40 ()
BCE4

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9801 Sensors -or- (2) 9830 sensors.
Tekscan, Inc.
Prosthetic 1 (1 Handle) System
In Commercial Distribution

  • B970PE10 ()
PE1

  • Body-surface pressure mapping system
Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, SportsAT Software CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable
Tekscan, Inc.
MatScan VersaTek Platform with SportsAT Software
In Commercial Distribution

  • B970MV1SPORTS0 ()
MV1-SPORTS

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, (1) 4-Port Powered USB Hub, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 System
In Commercial Distribution

  • B970CCE20 ()
CCE2

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5400N Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5400N Sensors with 2 Sensor Covers or 1 Two-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE5400-2
In Commercial Distribution

  • B970BCE540020 ()
BCE5400-2

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5350 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5350 Sensors with 2 Sensor Covers or 1 Two-Pocket Sensor Cover and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5350 Sensors)
In Commercial Distribution

  • B970BCE535020 ()
BCE5350-2

  • Body-surface pressure mapping system
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