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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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CONFORMat Versatek - B970CCV10

Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, CONFORMat Clinical Software CD with CONFORMat Map, Help File and PDF of System Manual, (1)5330E Sensor, 10 ft. USB Cable, 25 ft. Cuff Cable, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 VersaTek System
In Commercial Distribution

  • B970CCV10 ()
CCV1

  • Body-surface pressure mapping system

tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition - 07540261015243

Airwave Oscillometry System (US version) compatible with ClearFlo PFT filter including power supply, ethernet cable, user manual, and packaged with accessories: tremoFlo unit (DI 07540261013362), test load (DI 07540261009860), CD containing US Software and digital User Manual (DI 07540261016400). System used to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Thorasys Thoracic Medical Systems Inc
101524
In Commercial Distribution

  • 07540261015243 ()


  • Pulmonary function analysis system, adult

Welch Allyn, Inc. - 00732094263152

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; Suction electrodes (6) and clamps (4); 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

  • 00732094263152 ()
RSCRIBE-6AC-DXCBB

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094325355

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

  • 00732094325355 ()
RSCRIBE-6AC-AXCAA

  • Electrocardiograph, professional, multichannel

HR Walkway VersaTek - B970HRV30

Includes 6 VersaTek Cuffs, 3 VersaTek 2-Port Hubs, 3 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101TL Map and 3 Equilibration Files, Help File and PDF of System Manual, 3 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 3 VersaTek System
In Commercial Distribution

  • B970HRV30 ()
HRV3

  • Body-surface pressure mapping system

HR Walkway VersaTek - B970HRV20

Includes 4 VersaTek Cuffs, 2 VersaTek 2-Port Hubs, 2 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101D Map with 3 Equilibration Files, Help File and PDF of System Manual, 2 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 2 VersaTek System
In Commercial Distribution

  • B970HRV20 ()
HRV2

  • Body-surface pressure mapping system

HR Mat VersaTek - B970HRV10

Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
HR Mat VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970HRV10 ()
HRV1

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094319033

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); AHA 10 wire, 12-lead lead set with medi-clip ends; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094319033 ()
RSCRIBE-6BC-XXACA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094262988

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; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094262988 ()
RSCRIBE-6GC-XXCBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094262995

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); 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

  • 00732094262995 ()
RSCRIBE-6GC-XXCAA

  • Electrocardiograph, professional, multichannel
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