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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Q-Tel RMS Main Tower with support for up to 12 Welch Allyn S2 Telemetry Transmitters.
WELCH ALLYN, INC.
901145
Not in Commercial Distribution

  • 00732094325973 ()
QTELM-Q-CAAA

  • Centralized patient monitor
Q-Tel RMS Secondary Tower with support for up to 12 Welch Allyn S2 Telemetry Transmitters.
WELCH ALLYN, INC.
901145
Not in Commercial Distribution

  • 00732094325966 ()
QTELS-Q-C

  • Centralized patient monitor
ENG CTRL TELEM 110 VAC 32S 24C S4 SATA
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094325874 ()
SCNODE-AAA-CMBFX

  • 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

  • 00732094325867 ()
SCSYS-HAE-GHFCA

  • 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); 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.
901137
In Commercial Distribution

  • 00732094325850 ()
SCSYS-HAE-LBFCA

  • 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

  • 00732094325843 ()
SCSYS-HAE-LHFCA

  • 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); 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 monit
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094325669 ()
SCSYS-HAE-GBFCA

  • Centralized patient monitor
Surveyor Repeater Node with no Hardware Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901140
Not in Commercial Distribution

  • 00732094325362 ()
SCREP-DEB-XXXXX

  • Centralized patient monitor
ITA CTRL TELEM 220 VAC 32S 24C S4
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094325287 ()
SCNODE-BEB-CMXXX

  • Centralized patient monitor
ENG. 110V S4 16SL 8CH LOCAL STORAGE
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094325270 ()
SCNODE-AAA-BKBEX

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

  • 00732094325102 ()
SCSYS-IAE-UFFAX

  • Centralized patient monitor
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
CONNEX CENTRAL STATION 1.8.1 SW ONLY
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094320138 ()
107985

  • 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; 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 with 12-lead ECG interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320084 ()
SCSYS-HAE-SHFAA

  • 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,
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320008 ()
SCSYS-HAE-GHFAX

  • Centralized patient monitor
SOFTWARE SURVYOR CENTRAL REPEATER DVD
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094319903 ()
419832

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 8 monitoring slots (single display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094319743 ()
SCAC-AAA-BXCXX

  • Centralized patient monitor
Surveyor Central Repeater Standalone - English language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094319408 ()
SCREP-CAB-XXXXX

  • 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
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