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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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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. - 00732094263060

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; 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

  • 00732094263060 ()
RSCRIBE-6CC-XXDBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263053

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No 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

  • 00732094263053 ()
RSCRIBE-6EC-XXDBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263046

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263046 ()
RSCRIBE-6EC-XXDBB

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094262940

RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); IEC 10 wire, 12-lead lead set with banana plugs; No connectivity
WELCH ALLYN, INC.
901127
Not in Commercial Distribution

  • 00732094262940 ()
RSCRIBE-7CC-XXABX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094319415

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; No accessories; AHA 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

  • 00732094319415 ()
RSCRIBE-6GC-XXDAC

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094309294

Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309294 ()
H12PLUS-JPB-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309270

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); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309270 ()
H12PLUS-KPB-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309201

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

  • 00732094309201 ()
RSCRIBE-6GC-XXCBX

  • Electrocardiograph, professional, multichannel
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