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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ENGLISH 220V 8 SL LOCAL S4
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094324228 ()
SCNODE-AAB-AJBXX

  • 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 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 w/ 12-lead ECG interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094323740 ()
SCSYS-IAE-SHFCA

  • 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; 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,
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094323290 ()
SCSYS-IED-SDFCX

  • 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 110V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 8 telemetry channels (dual display recommended); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094323283 ()
SCSYS-IAE-FBFXX

  • 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; 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
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094322361 ()
SCSYS-IED-SDFEX

  • Centralized patient monitor
Surveyor Central Station w/ S4 Wifi telemetry mon. capabilities; EN lang & CD manual; Config. CPU w/ 110V pwr & dual color LCD 24" mon.s w/ high res; Custom number of hard wired patient mon. slots & telemetry channels; Redundant server (RAID1+0) storage 1,200 days, 110V HP LaserJet printer; VERITAS analysis algorithm w/ 12-lead ECG interp, ext arrhythmia, 12-lead ST segment mon., & hemodynamic calc (req options w/ hard wired patient mon. slots); Full disclosure & SC Interface; Protocol manager
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320824 ()
SCSYS-HAE-SHFCA

  • 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; 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
CONNEX CSAS 1.8.1 EPISODIC
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094320169 ()
107980

  • Centralized patient monitor
CSAS 1.8.1 CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094320152 ()
107981

  • Centralized patient monitor
CONNEX CENTRAL STATION 1.8.1 - HW & SW
WELCH ALLYN, INC.
901066
Not in Commercial Distribution

  • 00732094320145 ()
107984

  • Centralized patient monitor
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