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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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Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system
Measuring blood pressure
Banclar Corp.
PG-800B19L
In Commercial Distribution

  • G467101112BC0 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Cardio Card NIBP noninvasive blood pressure
NASIFF ASSOCIATES INC
CUSBNIBP
In Commercial Distribution

  • G466CUSBNIBP0 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Includes 3140 Sensor installed in Presto-Scan display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, Presto-Scan Software CD with 3140 Map, and Quick Start Guide
Tekscan, Inc.
Presto-Scan System
In Commercial Distribution

  • B970ZPKGPRESTOSCANEVOL0 ()
ZPKG-PRESTOSCAN-EVOLUTION

  • Body-surface pressure mapping system
HR Mat Assembly: Includes sensor and platform
Tekscan, Inc.
HR Mat
In Commercial Distribution

  • B970ZPKGHIRESFLRFLRE0 ()
ZPKG-HIRES-FLR-FLR-E

  • Body-surface pressure mapping system
1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder and Belt
Tekscan, Inc.
VersaTek Wireless Datalogger
In Commercial Distribution

  • B970VWD10 ()
VWD-1

  • Body-surface pressure mapping system
1 VersaTek Wireless Unit with Battery Pack Holder and Belt
Tekscan, Inc.
Versatek Wireless
In Commercial Distribution

  • B970VW10 ()
VW-1

  • Body-surface pressure mapping system
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
1 VersaTek Datalogger Unit with Battery Pack Holder and Belt
Tekscan, Inc.
VersaTek Datalogger
In Commercial Distribution

  • B970VDL10 ()
VDL-1

  • Body-surface pressure mapping system
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