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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 1 VersaTek Cuff, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat Map, Help File, PDF of System Manual, Pre-configured wireless router, (1) 5330E Sensor, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (1) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 1 Arm/Leg Strap, 1 Velcro Cable Tie, 1 Velcro Wrist/Ankle Band, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 1 VersaTek Wireless System
In Commercial Distribution

  • B970CVW10 ()
CVW1

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Datalogger software features, (2) 5330E Sensors, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek Datalogger System
In Commercial Distribution

  • B970CVD20 ()
CVD2

  • 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
Includes 1 Evolution Handle, CONFORMat Clinical Software CD with CONFORMat Map, (1) 5330 Sensor, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 System
In Commercial Distribution

  • B970CE10 ()
CE1

  • 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
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, CONFORMat Clinical Software CD with CONFORMat Map, Help File and PDF of System Manual, (1)5330E Sensor, 10 ft. USB Cable, 25 ft. Cuff Cable, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 VersaTek System
In Commercial Distribution

  • B970CCV10 ()
CCV1

  • 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 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 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 1 Evolution Handle, BPMS Clinical Software CD with 5400N Sensor Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (1) 5400N Sensor with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5400N Sensors)
In Commercial Distribution

  • B970BCE540010 ()
BCE5400-1

  • Body-surface pressure mapping system
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