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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ENG 220V 16 S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262858 ()
SCNODE-AAB-BLBFX

  • Centralized patient monitor
ITA 220V 8 SL LOCAL S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262803 ()
SCNODE-AEB-AJBXX

  • Centralized patient monitor
ITA 220V CUSTOM
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262759 ()
SCNODE-AEB-CLBXX

  • Centralized patient monitor
ITA 220V CUSTOM
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262704 ()
SCNODE-AEB-EMBXX

  • Centralized patient monitor
POLISH 220V 8SL LOCAL
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262698 ()
SCNODE-AGB-AJBXX

  • Centralized patient monitor
ENG 220V 16 SLOTS 16 S4 WIDE-SCREEN LCD
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262681 ()
SCNODE-BAB-BLXFX

  • Centralized patient monitor
ENG 220V CUSTOM 24 S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262674 ()
SCNODE-BAB-EMXXX

  • Centralized patient monitor
GERMAN CONTROL 8SL 8 S4
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094262667 ()
SCNODE-BDB-AKXXX

  • Centralized patient monitor
DUTCH 220V 32SL
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262643 ()
SCNODE-BFB-CXXXX

  • Centralized patient monitor
ITA CONTROL 220V
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262575 ()
SCNODE-DEB-BLXXX

  • Centralized patient monitor
ITA. CONTROL 220V W 16 SLOTS
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262568 ()
SCNODE-DEB-BXXXX

  • Centralized patient monitor
ITA CONTROL 220V 16 S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262544 ()
SCNODE-DEB-DJXXX

  • Centralized patient monitor
ITA. CONTROL 220V W 4 SLOTS
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262537 ()
SCNODE-DEB-DXXXX

  • Centralized patient monitor
ITA. CONTROL 220V W 24 SLOTS CUSTOM
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262520 ()
SCNODE-DEB-EXXXX

  • Centralized patient monitor
DUTCH CONTROL 220V W 32 SLOTS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262513 ()
SCNODE-DFB-CXXXX

  • Centralized patient monitor
GERMAN 220V CUSTOM 24 S4 TELEMETRY
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262506 ()
SCNODE-EDB-EMXXX

  • Centralized patient monitor
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - English language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262483 ()
SCREP-BAB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - Italian language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262476 ()
SCREP-BEB-XXXXX

  • Centralized patient monitor
Surveyor Central Review Station - English 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

  • 00732094262452 ()
SCREV-AAB-AXXAX

  • Centralized patient monitor
Surveyor Central Review Station - English language and CD manual; 220V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262445 ()
SCREV-AAB-AXXXX

  • Centralized patient monitor
Surveyor Central Review Station - English language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262421 ()
SCREV-AAB-BXXXX

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

  • 00732094262407 ()
SCREV-AEB-BXXAX

  • Centralized patient monitor
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 and S12/S19 multiparameter bedside monitoring capabilities; German 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,
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262223 ()
SCSYS-IDB-SDFCA

  • 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; 4 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 mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262209 ()
SCSYS-IED-BBFAX

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

  • 00732094262193 ()
SCSYS-IED-CBFAX

  • 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 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, extended arrhythmia, 12-lead ST segment m
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262186 ()
SCSYS-IED-FBFAX

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

  • 00732094262131 ()
SCSYS-IED-LBFAX

  • 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 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 mon
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262117 ()
SCSYS-IED-QBFAX

  • 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 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 mon
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262100 ()
SCSYS-IED-QBFDX

  • 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; 4 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, 12-lead ST segment mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262094 ()
SCSYS-IED-TBFDX

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

  • 00732094262070 ()
SCSYS-IED-UBFDX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD m anual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 4 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 mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262063 ()
SCSYS-IGD-BBFXX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD m anual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 4 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, 12-lead ST segment mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262056 ()
SCSYS-IGD-TBFXX

  • Centralized patient monitor
106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094244298 ()
106900

  • Centralized patient monitor
CIWS STD STP SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094238853 ()
  • 00732094119299 ()
84XTVE

  • Multiple vital physiological parameter monitoring system, clinical
CIWS STD SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094238075 ()
  • 00732094056860 ()
84XXVE

  • Multiple vital physiological parameter monitoring system, clinical
Surveyor Central Additional Control - configured CPU English language and CD manual; 220V power; 24 monitoring slots (dual or 24 in. display required with additional CPU); No printer; Dual color LCD 24 in. monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262926 ()
SCAC-AAB-DXDXX

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 8 monitoring slots (single display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262902 ()
SCAC-AEB-BXXXX

  • Centralized patient monitor
ENG. 220V 8SL S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262889 ()
SCNODE-AAB-AJBEX

  • Centralized patient monitor
ENG. 220V 8 SL 8S4
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094262865 ()
SCNODE-AAB-AKBXX

  • Centralized patient monitor
ENG 220V 32 SL 32 CH S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262841 ()
SCNODE-AAB-CNBFX

  • Centralized patient monitor
ENG 110V 4 S4 LOCAL
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262834 ()
SCNODE-AAB-XJBXX

  • Centralized patient monitor
SPA. 220V S4 4 SLOT 4 REC R
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262827 ()
SCNODE-ABB-DJBXX

  • Centralized patient monitor
GERMAN 220V 8 SL 8S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262810 ()
SCNODE-ADB-AKBXX

  • Centralized patient monitor
ITA 220V 8 SL LOCAL 8S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262797 ()
SCNODE-AEB-AKBXX

  • Centralized patient monitor
CONTROL TELEMETRY STORAGE ITA
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262780 ()
SCNODE-AEB-AXBXX

  • Centralized patient monitor
ITA 220V 16SL 8 S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262773 ()
SCNODE-AEB-BKBXX

  • Centralized patient monitor
ITA 220V 16 S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262766 ()
SCNODE-AEB-BLBXX

  • Centralized patient monitor
ITA 220V 32SL 24 S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262742 ()
SCNODE-AEB-CMBXX

  • Centralized patient monitor
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