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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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KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography (Primary U-Arm Kit)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Primary
In Commercial Distribution

  • 00817100021268 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
Siemens Healthcare GmbH
11574001
In Commercial Distribution

  • 04056869962214 ()


  • Stationary basic diagnostic x-ray system, digital
set of 6 models Head support regular density extra soft (for Push Pin Hardware)
Orfit Industries NV
32450
In Commercial Distribution

  • 05420028702079 ()


  • DNA-based tissue typing IVD, reagent
Accessory Box single level, w/hardware (2 screws & nuts) 1.5" x 3.5" x 1"
Avalign Technologies, Inc.
95-2000100036
In Commercial Distribution

  • 00190776121471 ()


  • Device sterilization/disinfection container, reusable
Manometer, Wall Mount Dovetail, Removable Vertical Mount w/Hardware, fits all 00-199, 00-274 Gauges
ANESTHESIA ASSOCIATES, INC.
00-195
In Commercial Distribution

  • B005001950 ()
00-195

  • Airway pressure monitor, non-powered
ENG CONTROL 220V 50HZ W 8 SLOTS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351279 ()
SCNODE-DAB-AXXFX

  • 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 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
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 8 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 inte
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351255 ()
SCSYS-IAB-FDFCA

  • Centralized patient monitor
ENG CONTROL & TELEM 220V 50HZ W 8 SLOTS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351248 ()
SCNODE-BAB-AKXFX

  • 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 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
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