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 110 VAC 32S S4 SATAS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345568 ()
SCNODE-CAA-CXBFX

  • 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; 24 hard wired patient monitoring slots and 0 telemetry channels (dual display required); Local storage for up to 600 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345551 ()
SCSYS-IAE-HFFAX

  • 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; 16 hard wired patient monitoring slots and 0 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

  • 00732094345346 ()
SCSYS-IAE-DBFAX

  • Centralized patient monitor
GER TELEM 220 VAC 32S
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094341492 ()
SCNODE-DDB-CXXFX

  • 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; 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 segment monitoring, and hemodynam
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094339437 ()
SCSYS-HAD-SDFCA

  • Centralized patient monitor
ENG TELEM 110 VAC 16S 8C S4 SAS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094339024 ()
SCNODE-BAA-BKXEX

  • 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; 8 hard wired patient monitoring slots and 8 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 arrhythmi
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094339017 ()
SCSYS-HAE-FHFCA

  • Centralized patient monitor
CONNEX CSAS 1.8.3 EPISODIC
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094337044 ()
108141

  • Centralized patient monitor
CSAS 1.8.3 CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094337037 ()
108142

  • Centralized patient monitor
CONNEX CENTRAL STATION 1.8.3 SW ONLY
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094337020 ()
108143

  • Centralized patient monitor
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