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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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SC Station S4 Wifi telemetry and S12/S19 multiparameter bedside monitor capabilities EN CD man Config CPU custom SCNODE config must be determined w/ 110V pwr and dual color LCD 24" high res monitor 16 hard wired pat. monitor slots and 0 telemetry ch dual display recommend Local storage 600 days no network printer VERITAS analysis algorithm 12-lead ECG interp ext. arrhythmia 12-lead ST segment monitor and hemodynamic calc required for options with hard wired pat. monitor slots No full disclosure
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094318234 ()
SCSYS-IAA-DBFXX

  • Centralized patient monitor
Surveyor Central Review Station - ; English language and CD manual; 110V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; Color LCD 24" monitor with high resolution; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export; Surveyor Central Review Station - ; English language and CD manual; 110V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; Color LCD 24" monitor with high resolution; VERITAS analysis algorithm wit
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094318159 ()
SCREV-AAA-AXBAX

  • 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" 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, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-le
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094317510 ()
SCSYS-HAB-RDFEA

  • 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" monitors with high resolution; 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 monitori
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094315769 ()
SCYSYS-HAB-CBFCA

  • 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 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, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094315585 ()
SCSYS-HAF-LHFAA

  • Centralized patient monitor
Surveyor Central Review Station - ; English language and CD manual; 220V power; Software kit; No printer; Color LCD 24" monitor with high resolution; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export;
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094314267 ()
SCREV-AAB-BXBAX

  • 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" monitors with high resolution; 0 hard wired patient monitoring slots and 8 telemetry channels (single display required); Local storage for up to 600 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094314250 ()
SCSYS-HAE-CFFAX

  • 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" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); 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
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094314243 ()
SCSYS-HAB-GDFEA

  • Centralized patient monitor
Spot 4400 with NIBP SureTemp and Nonin
WELCH ALLYN, INC.
901057
In Commercial Distribution

  • 00732094309409 ()
  • 00732094309232 ()
  • 00732094326741 ()
  • 00732094309447 ()
  • 00732094309454 ()
  • 00732094309461 ()
  • 00732094309393 ()
44WT

  • Multiple vital physiological parameter monitoring system, clinical
Spot 4400 with NIBP and SureTemp
WELCH ALLYN, INC.
901057
In Commercial Distribution

  • 00732094309386 ()
  • 00732094309225 ()
  • 00732094309324 ()
  • 00732094309317 ()
  • 00732094309362 ()
  • 00732094309379 ()
44XT

  • Multiple vital physiological parameter monitoring system, clinical
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; 12 hard wired patient monitoring slots and 4 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

  • 00732094308891 ()
SCSYS-IAE-EBFAX

  • Centralized patient monitor
Surveyor Central Repeater Standalone - Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094308778 ()
SCREP-CEB-XXXXX

  • 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" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythm
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094308396 ()
SCSYS-HAE-GHFAA

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

  • 00732094308389 ()
SCSYS-HAE-LHFAA

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 16 monitoring slots (dual or 24" display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094308327 ()
SCAC-AAA-CXCXX

  • Centralized patient monitor
ENG. 110V 32SL 608MHz W MONITORS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094307900 ()
SCNODE-BAA-CNXFX

  • 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" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); 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

  • 00732094307894 ()
SCSYS-HAE-GHCAA

  • 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" 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 monitoring;
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094307887 ()
SCSYS-HAE-RHCAA

  • 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" monitors with high resolution; 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 monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094307849 ()
SCSYS-HAE-CBFAX

  • 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; 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 arr
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094307429 ()
SCSYS-IAE-UBFXX

  • Centralized patient monitor
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