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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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
ENG. 220V STORAGE NO MONITORS NO-SW
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094335958 ()
SCNODE-GAB-XXDXS

  • Centralized patient monitor
ENG. 110V STORAGE NO-SW
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094335927 ()
SCNODE-GAA-XXDDS

  • Centralized patient monitor
STORAGE ENG. 110V REDUNDANT CAP NO-SW
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094335910 ()
SCNODE-GAA-XXDXS

  • 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 8 telemetry channels (single 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

  • 00732094333329 ()
SCSYS-HAE-CHFCA

  • Centralized patient monitor
SCS MIX ENG 110V 32SL-8TEL 600D FD
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094328981 ()
SCSYS-IAE-OBFAX

  • Centralized patient monitor
ENG TELEM 110 VAC 32S 8C S4 SATA
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094328974 ()
SCNODE-AAA-CKBFX

  • Centralized patient monitor
CONNEX CSAS 1.8.2 EPISODIC
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094327144 ()
108111

  • Centralized patient monitor
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