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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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ITA. 4 SLOT CONTROL 220V
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262728 ()
SCNODE-AEB-DXBXX

  • Centralized patient monitor
ITA. CONTROL 220V W 8 SLOTS
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262582 ()
SCNODE-DEB-AXXXX

  • 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; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262391 ()
SCREV-AEB-BXXXX

  • 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 monitoring capabilities; English 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, extended arrhythmia, 12-lead ST se
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262377 ()
SCSYS-HAB-SDFAA

  • 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; 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 monitoring, and hemodynamic calc
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262353 ()
SCSYS-HAD-CBFXX

  • 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; 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 monitoring, and hemodynamic calculati
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262339 ()
SCSYS-HAD-UBFXX

  • 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 in. 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 monitorin
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262322 ()
SCSYS-HAE-RHCCX

  • Centralized patient monitor
ACCY SENSOR TEMP SKIN DISPOSABLE
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094253238 ()
725952

  • Multiple vital physiological parameter monitoring system, clinical
1.7 CONNEX WARM SPARE STATION
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094253207 ()
107057

  • Centralized patient monitor
1.7.1 CONNEX WARM SPARE STATION
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094253191 ()
107055

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

  • 00732094253184 ()
107053

  • Centralized patient monitor
CONNEX CSAS CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250886 ()
106901

  • Centralized patient monitor
CONNEX CS SOFTWARE DELIVERY PHANTOM
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250879 ()
411066

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

  • 00732094247060 ()
  • 00732094247282 ()
68NCDP

  • Multiple vital physiological parameter monitoring system, clinical
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
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