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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 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
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
MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.13
In Commercial Distribution

  • 00850009343130 ()


  • Radiological PACS software
MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.12
Not in Commercial Distribution

  • 00850009343031 ()


  • Radiological PACS software
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 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 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
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 - I3 = Resting-ECG Measurement and Interpretation MEANS (Uni. of Rotterdam, NL) - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I3-D1
In Commercial Distribution

  • 07290110252816 ()
HASP-SW-K-S2I3D1-01

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