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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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Welch Allyn, Inc. - 00732094262094

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

Welch Allyn, Inc. - 00732094262087

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

  • 00732094262087 ()
SCSYS-IED-UBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262070

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

Welch Allyn, Inc. - 00732094262063

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

Welch Allyn, Inc. - 00732094262056

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

Welch Allyn, Inc. - 00732094258998

KIT Q-TEL CHNL UPG 4-12 608MHZ
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094258998 ()
036840-005

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094253238

ACCY SENSOR TEMP SKIN DISPOSABLE
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094253238 ()
725952

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094253207

1.7 CONNEX WARM SPARE STATION
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094253207 ()
107057

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094253191

1.7.1 CONNEX WARM SPARE STATION
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094253191 ()
107055

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094253184

1.7.1 CONNEX CENTRAL STATION SW
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094253184 ()
107053

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094250886

CONNEX CSAS CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250886 ()
106901

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094250879

CONNEX CS SOFTWARE DELIVERY PHANTOM
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250879 ()
411066

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094247282

68NCDP VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
Not in Commercial Distribution

  • 00732094247060 ()
  • 00732094247282 ()
68NCDP

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094244298

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

Welch Allyn, Inc. - 00732094238853

CIWS STD STP SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094238853 ()
  • 00732094119299 ()
84XTVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094238075

CIWS STD SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094238075 ()
  • 00732094056860 ()
84XXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094319064

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

Welch Allyn, Inc. - 00732094318937

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

  • 00732094318937 ()
SCNODE-DAA-CXXFX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094318920

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

Welch Allyn, Inc. - 00732094318234

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

Welch Allyn, Inc. - 00732094318159

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

Welch Allyn, Inc. - 00732094317510

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

Welch Allyn, Inc. - 00732094315769

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

Welch Allyn, Inc. - 00732094315585

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

Welch Allyn, Inc. - 00732094314267

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

Welch Allyn, Inc. - 00732094314250

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

Welch Allyn, Inc. - 00732094314243

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

Welch Allyn, Inc. - 00732094309232

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

Welch Allyn, Inc. - 00732094309225

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

Welch Allyn, Inc. - 00732094308891

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

Welch Allyn, Inc. - 00732094308778

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

Welch Allyn, Inc. - 00732094308396

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

Welch Allyn, Inc. - 00732094308389

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

Welch Allyn, Inc. - 00732094308327

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

Welch Allyn, Inc. - 00732094307900

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

  • 00732094307900 ()
SCNODE-BAA-CNXFX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094307894

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

Welch Allyn, Inc. - 00732094307887

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

Welch Allyn, Inc. - 00732094307849

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

Welch Allyn, Inc. - 00732094307429

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

Welch Allyn, Inc. - 00732094307412

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 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 arr
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094307412 ()
SCSYS-IAE-CBFXX

  • Centralized patient monitor
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