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 Review Station - Dutch language and CD manual; 220V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; No display monitor; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262384 ()
SCREV-AFB-AXXAX

  • 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 dual color LCD 24 in. 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, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST se
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262377 ()
SCSYS-HAB-SDFAA

  • 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 dual color LCD 24 in. 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; 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring; Full disc
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262360 ()
SCSYS-HAB-SHCCA

  • 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 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 calc
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262353 ()
SCSYS-HAD-CBFXX

  • 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; 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 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 monitoring, and hemodynamic calculati
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262339 ()
SCSYS-HAD-UBFXX

  • 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 110V power and dual color LCD 24 in. monitors with high resolution; 0 hard wired patient monitoring slots and 32 telemetry channels (dual display required); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitorin
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262322 ()
SCSYS-HAE-RHCCX

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

  • 00732094262315 ()
SCSYS-HBD-UBFAX

  • 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
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