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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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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; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); AHA 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

  • 00732094263169 ()
RSCRIBE-6AC-AXDBB

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; WAM Wireless 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; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
Not in Commercial Distribution

  • 00732094262964 ()
RSCRIBE-7AC-XXABA

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; WAM Wireless 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; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
Not in Commercial Distribution

  • 00732094262957 ()
RSCRIBE-7AC-XXABB

  • Electrocardiograph, professional, multichannel
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; Snap adapters (set of 10) and monitoring electrodes (pouch of 10); AHA 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

  • 00732094263138 ()
RSCRIBE-6AC-XXBAB

  • Electrocardiograph, professional, multichannel
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; Snap adapters (set of 10) and monitoring electrodes (pouch of 10); 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

  • 00732094263084 ()
RSCRIBE-6CC-XXBAA

  • Electrocardiograph, professional, multichannel
No Description
Lonza Verviers
BE12-771P20
In Commercial Distribution

  • 05407010120219 ()


  • Cell culture medium IVD
No Description
Lonza Verviers
BE12-771P10
In Commercial Distribution

  • 05407010120202 ()


  • Cell culture medium IVD
Includes 14 VersaTek Cuffs, 7 VersaTek 2-Port Hubs, 7 Power Supplies, 1 Multi-Port Powered USB Hub, Walkway Software CD with 7101_HRV7 Map and 3 Equilibration Files, Help File and PDF of System Manual, 7 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 7 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 7 VersaTek System
In Commercial Distribution

  • B970HRV70 ()
HRV7

  • Body-surface pressure mapping system
Includes 12 VersaTek Cuffs, 6 VersaTek 2-Port Hubs, 6 Power Supplies, 1 Multi-Port Powered USB Hub, Walkway Software CD with 7101HL Map and 3 Equilibration Files, Help File and PDF of System Manual, 6 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 6 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 6 VersaTek System
In Commercial Distribution

  • B970HRV60 ()
HRV6

  • Body-surface pressure mapping system
Includes 10 VersaTek Cuffs, 5 VersaTek 2-Port Hubs, 5 Power Supplies, 1 Multi-Port Powered USB Hub, Walkway Software CD with 7101PL Map and 3 Equilibration Files, Help File and PDF of System Manual, 5 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 5 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 5 VersaTek System
In Commercial Distribution

  • B970HRV50 ()
HRV5

  • Body-surface pressure mapping system
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