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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; 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
SCS w/ S4 Wifi telemetry & S12/S19 bedside moning; EN language CD manual; CPU(SCNODE config must be determined) w/ 110V pwr & dual color LCD 24" mons w/ high res; 8 telemetry channels (single display required); Loc storage 600 days, 110V HP LaserJet printer; VERITAS analysis algorithm w/ 12-lead ECG interp, ext arrhythmia, 12-lead ST segment mon, & hemodynamic calc(required for opw/ hard wired pat mon slots); Full disclosure & SC Interface; Protocol mgr, per channel
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094319064 ()
SCSYS-IAE-CFFCA

  • Centralized patient monitor
ENG 110 VAC 60 Hz 32Slot Dual 24 LCD
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094318937 ()
SCNODE-DAA-CXXFX

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; Custom display and control (Project Management required); 110V HP LaserJet network printer; Dual color LCD 24" monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094318920 ()
SCAC-AAA-EADXX

  • Centralized patient monitor
CSAS Episodic High Availability
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094345704 ()
106900-HA

  • Centralized patient monitor
ENG 110 VAC 32S S4 SATAS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345568 ()
SCNODE-CAA-CXBFX

  • 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; 24 hard wired patient monitoring slots and 0 telemetry channels (dual display required); Local storage for up to 600 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345551 ()
SCSYS-IAE-HFFAX

  • 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; 16 hard wired patient monitoring slots and 0 telemetry channels (dual display recommended); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended a
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345346 ()
SCSYS-IAE-DBFAX

  • Centralized patient monitor
GER TELEM 220 VAC 32S
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094341492 ()
SCNODE-DDB-CXXFX

  • 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; 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 segment monitoring, and hemodynam
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094339437 ()
SCSYS-HAD-SDFCA

  • Centralized patient monitor
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