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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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MIMcloud - 00850009343130

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 - 00850009343031

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

Norav 1200 Series PC-ECG - 07290110252816

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

PowerCHO-2 CD, w/o L-Gln w/o PR or HT,1L - 05407010120493

No Description
Lonza Verviers
BEBP12-771Q
In Commercial Distribution

  • 05407010120493 ()


  • Cell culture medium IVD

PowerCHO-2 CD, w/o L-Gln w/o PR or HT,1L - 05407010122701

No Description
Lonza Verviers
BELN12-771Q
In Commercial Distribution

  • 05407010122701 ()


  • Cell culture medium IVD

F-Socket Versatek - B970SV10

Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (1 Cuff) System
In Commercial Distribution

  • B970SV10 ()
SV1

  • Body-surface pressure mapping system

HR Walkway VersaTek - B970HRV40

Includes 8 VersaTek Cuffs, 4 VersaTek 2-Port Hubs, 4 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101QL Map and 3 Equilibration Files, Help File and PDF of System Manual, 4 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 4 AC Power Cords, 4 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 4 VersaTek System
In Commercial Distribution

  • B970HRV40 ()
HRV4

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094320237

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 8 hard wired patient monitoring slots and 0 telemetry channels (single display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320237 ()
SCSYS-IED-ABFCX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094320084

Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 110V power and dual color LCD 24" monitors with high resolution; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320084 ()
SCSYS-HAE-SHFAA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094301137

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0 hard wired patient monitoring slots and 4 telemetry channels (single display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094301137 ()
SCSYS-IGD-UBFXX

  • Centralized patient monitor
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