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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 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
Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5315 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5315 Sensors with 2 Sensor Covers or 1 Two-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5315 Sensors)
In Commercial Distribution

  • B970BCE531520 ()
BCE5315-2

  • Body-surface pressure mapping system
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB or SD Card Reader (for DL800/900 recorders) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-4
In Commercial Distribution

  • 07290110254995 ()
HASP-SW-K-NH301-4-04

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2
In Commercial Distribution

  • 07290110252779 ()
HASP-SW-K-S2-01

  • Cardiopulmonary stress exercise monitoring system computer
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; No power cord; No printer; No accessories; 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

  • 00732094319026 ()
RSCRIBE-6BC-XXDAA

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module, Non-interpretive; Software kit; International power cord; No printer; No accessories; 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

  • 00732094285574 ()
RSCRIBE-6DC-DXDBA

  • Electrocardiograph, professional, multichannel
Includes 2 Evolution Handles, 1 Four-Port USB Hub, Research Walkway Software CD with 5400ND Map, Help File and PDF of System Manual, 2 HugeMat 5400N Sensors pre-assembled into a single floor display, Neoprene Cover (12'x3'), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA only)
Tekscan, Inc.
HugeMat Walkway 2 Evolution System
In Commercial Distribution

  • B970MXLE20 ()
MXLE2

  • Body-surface pressure mapping system
Norav 1200 Series PC-ECG Software Upgrade Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2toS2
In Commercial Distribution

  • 07290110252786 ()
HASP-SW-K-S2-S1-01

  • Cardiopulmonary stress exercise monitoring system computer
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; International power cord; No printer; No accessories; 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

  • 00732094263145 ()
RSCRIBE-6AC-DXDBA

  • Electrocardiograph, professional, multichannel
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