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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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BPMS Evolution - B970BCE540020

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

BPMS Evolution - B970BCE535020

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

BPMS Evolution - B970BCE531520

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 - 07290110254995

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 - 07290110252779

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

Welch Allyn, Inc. - 00732094319026

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

Welch Allyn, Inc. - 00732094285574

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

Huge-Mat Evolution - B970MXLE20

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 - 07290110252786

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

Welch Allyn, Inc. - 00732094263145

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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