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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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Welch Allyn, Inc. - 00732094309287

Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309287 ()
H12PLUS-KPA-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094283419

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; 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

  • 00732094283419 ()
RSCRIBE-6AC-XXDAA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00817655023311

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); 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

  • 00817655023311 ()
RSCRIBE-6AC-XXCAA

  • Electrocardiograph, professional, multichannel

MatScan VersaTek - B970MV1RES0

Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Researchers CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan VersaTek Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970MV1RES0 ()
MV1-RES

  • Body-surface pressure mapping system

MatScan VersaTek - B970MV10

Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Clinicians CD with MatScan 3150 Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970MV10 ()
MV1

  • Body-surface pressure mapping system

Norav 1200 Series PC-ECG - 07290110255022

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 - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I2
In Commercial Distribution

  • 07290110255022 ()
HASP-SW-K-S2I2-01

  • Patient-administration information system application software
  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer

Norav 1200 Series PC-ECG - 07290110252793

Norav 1200 Series PC-ECG Software Kit for COSMED 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 - I1 = Restin-ECG Measurement The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution

  • 07290110252793 ()
HASP-SW-K-S2I1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263077

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); 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

  • 00732094263077 ()
RSCRIBE-6CC-XXCBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094337877

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); 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

  • 00732094337877 ()
RSCRIBE-6AC-XXCBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094262971

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Brazil INMETRO labeling; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); IEC 10 wire, 12-lead lead set with banana plugs; Interface with remote RScribe database (requires RScribe database server)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094262971 ()
RSCRIBE-6GC-XXCBC

  • Electrocardiograph, professional, multichannel
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