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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. - 00732094351262

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 220V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 0 telemetry channels (single display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351262 ()
SCSYS-IAB-ADFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094351231

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 220V 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, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351231 ()
SCSYS-IAB-CDFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094345551

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

F-Scan Versatek - B970FV20

Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, Waist Belt, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek System
In Commercial Distribution

  • B970FV20 ()
FV2

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094320824

Surveyor Central Station w/ S4 Wifi telemetry mon. capabilities; EN lang & CD manual; Config. CPU w/ 110V pwr & dual color LCD 24" mon.s w/ high res; Custom number of hard wired patient mon. slots & telemetry channels; Redundant server (RAID1+0) storage 1,200 days, 110V HP LaserJet printer; VERITAS analysis algorithm w/ 12-lead ECG interp, ext arrhythmia, 12-lead ST segment mon., & hemodynamic calc (req options w/ hard wired patient mon. slots); Full disclosure & SC Interface; Protocol manager
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320824 ()
SCSYS-HAE-SHFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094318432

Q-Stress Cardiac ver 6 w/ adult & ped interpretation; inc current sfw user manual CD; AM12Q Wired Acquisition Module w/ Trigger Module for TTL/analog signal output;Turnkey system w/ configured CPU & color LCD 24" mon w/ 1920 x 1080 res UK power cord; Z200+ thermal printer,( 2 packs full-grid paper A4), Q-Stress premium cart w/ base, keyboard tray, shelf, large drawer,storage pocket; IEC 10 wire, 12-lead set w/ medi-clips; Iso trans 1000 VA Med Global;Export XML Orders
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318432 ()
QS-6ED-CFEAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094358322

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and Web Direct Card for IFUs; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q ONLY;
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094358322 ()
QS-6AA-AGAAA

  • Cardiopulmonary stress exercise monitoring system

Welch Allyn, Inc. - 00732094358315

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and Web Direct Card for IFUs; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wi
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094358315 ()
QS-6EA-AEDAA

  • Cardiopulmonary stress exercise monitoring system

Welch Allyn, Inc. - 00732094358308

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and Web Direct Card for IFUs; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips for WAM ONLY; Isolation tran
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094358308 ()
QS-6EA-AGDAA

  • Cardiopulmonary stress exercise monitoring system

Welch Allyn, Inc. - 00732094358292

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and Web Direct Card for IFUs; WAM Wireless Acquisition Module; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi- clips for WAM ONL
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094358292 ()
QS-6FA-AEDAA

  • Cardiopulmonary stress exercise monitoring system
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