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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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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
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 4 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

  • 00732094284744 ()
SCSYS-IAD-BBFAX

  • Centralized patient monitor
Includes 2 VersaTek Cuffs, 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, (2) 25 ft. Cuff Cables, 2 Velcro Wrist/Ankle Bands, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (2 Cuff) System
In Commercial Distribution

  • B970SV20 ()
SV2

  • Body-surface pressure mapping system
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD m anual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0; Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and hemodynamic calculations (required for options with hard wired patient mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00817655023274 ()
SCSYS-IGD-ABFXX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English 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 24 telemetry channels (dual display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262346 ()
SCSYS-HAD-LDFCA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; German 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 8 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, 12-lead ST segment monitoring, and hemodynamic calculatio
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262308 ()
SCSYS-HDD-CBFAX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; German 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 8 telemetry channels (single display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262292 ()
SCSYS-HDD-CDFAX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English 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 8 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, 12-lead ST segment mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262230 ()
SCSYS-IAD-CBFAX

  • Centralized patient monitor
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; 0; Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and hemodynamic calculations (required for options with hard wired patient m
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262216 ()
SCSYS-IED-ABFAX

  • Centralized patient monitor
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; 4 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, 12-lead ST segment mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262209 ()
SCSYS-IED-BBFAX

  • Centralized patient monitor
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