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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. - 00732094262735

ITAL. 220V 4 SL 4 CONFIGURE for 4 S4
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262735 ()
SCNODE-AEB-DJBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262728

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

  • 00732094262728 ()
SCNODE-AEB-DXBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262711

ITA 220V CUSTOM
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262711 ()
SCNODE-AEB-ELBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262650

GERMAN CONTROL CUSTOM 16 S4 DISP 48
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262650 ()
SCNODE-BDB-ELXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262636

ITA. 8 SLOT CONTROL 220V
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262636 ()
SCNODE-CEB-AXBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262629

CONTROL STORAGE 4SL
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262629 ()
SCNODE-CGB-DXBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262612

ENG. 220V 16 SLOT- CONTROL
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262612 ()
SCNODE-DAB-BXXFX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262605

CONTROL ENG 220V CUSTOM
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262605 ()
SCNODE-DAB-EXXFX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262599

ITA CONTROL 200V 8 SLOTS
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262599 ()
SCNODE-DEB-AKXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262582

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

  • 00732094262582 ()
SCNODE-DEB-AXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262551

ITA. CONTROL 220V W 32 SLOTS
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094262551 ()
SCNODE-DEB-CXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262490

Surveyor Central Repeater Node - Dutch language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262490 ()
SCREP-AFB-XXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262469

Not a valid configuration
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262469 ()
SCREV-AAA-XXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262438

Surveyor Central Review Station - English language and CD manual; 220V power; Software kit; No printer; No display monitor; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262438 ()
SCREV-AAB-BXXAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262414

Surveyor Central Review Station - German language and CD manual; 220V power; Software kit; No printer; No display monitor; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262414 ()
SCREV-ADB-BXXAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262391

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

Welch Allyn, Inc. - 00732094262377

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

Welch Allyn, Inc. - 00732094262360

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, 110V HP LaserJet network printer; 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring; Full disc
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262360 ()
SCSYS-HAB-SHCCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262353

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

Welch Allyn, Inc. - 00732094262346

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 24 telemetry channels (dual display required); 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
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262346 ()
SCSYS-HAD-LDFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262339

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

Welch Allyn, Inc. - 00732094262322

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

Welch Allyn, Inc. - 00732094262315

Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; Spanish 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

  • 00732094262315 ()
SCSYS-HBD-UBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262308

Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; German 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 calculatio
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262308 ()
SCSYS-HDD-CBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262292

Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; German 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); 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
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262292 ()
SCSYS-HDD-CDFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262285

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 in. monitors with high resolution; 4 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 a
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262285 ()
SCSYS-IAB-BBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262278

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 in. monitors with high resolution; 0 hard wired patient monitoring slots and 16 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
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262278 ()
SCSYS-IAB-GBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262261

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 in. monitors with high resolution; 0 hard wired patient monitoring slots and 32 telemetry channels (dual display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended ar
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262261 ()
SCSYS-IAB-RBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262254

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 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; 12-lead ECG interpretation, extended arrhythmia, 12-lead ST
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262254 ()
SCSYS-IAB-SDCCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262247

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 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,
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262247 ()
SCSYS-IAB-SDFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262230

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 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 mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262230 ()
SCSYS-IAD-CBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262216

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0; 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 calculations (required for options with hard wired patient m
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262216 ()
SCSYS-IED-ABFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262179

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian 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 16 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 arrhythmia, 12-lead ST segment
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262179 ()
SCSYS-IED-GBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262162

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian 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 16 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 arrhythmia, 12-lead ST segment
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262162 ()
SCSYS-IED-GBFDX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262155

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 16 hard wired patient monitoring slots and 8 telemetry channels (dual 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 mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262155 ()
SCSYS-IED-JBFDX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262148

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 8 hard wired patient monitoring slots and 16 telemetry channels (dual 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 mon
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262148 ()
SCSYS-IED-KBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262124

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 16 hard wired patient monitoring slots and 16 telemetry channels (dual 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 mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262124 ()
SCSYS-IED-PBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262087

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian 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 mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262087 ()
SCSYS-IED-UBFAX

  • Centralized patient monitor

ZOLL Arrhythmia Management System - 00855778005463

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005463 ()
10A1112

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005456

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005456 ()
10A1107

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System - 00855778005364

No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution

  • 00855778005364 ()
10A1088

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System - 00855778005357

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005357 ()
10A1087

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005326

No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution

  • 00855778005326 ()
10A1073

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Charger - 00855778005319

No Description
ZOLL MANUFACTURING CORPORATION
Charger
In Commercial Distribution

  • 00855778005319 ()
10A1072

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005302

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005302 ()
10A1071

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Patch - 00855778005258

No Description
ZOLL MANUFACTURING CORPORATION
Patch
In Commercial Distribution

  • 00855778005258 ()
10A1067

  • Wearable multiple vital physiological parameter monitoring system

GutTracker - 00860011391500

GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
G-TECH MEDICAL, INC.
Gen 2
In Commercial Distribution

  • 00860011391500 ()
  • 00860011391517 ()

  • Length: 3.3 Inch
1001

  • Wearable multiple vital physiological parameter monitoring system

Sirona Medical Radiology Platform - 00860011175803

No Description
Sirona Medical, Inc.
Model1
In Commercial Distribution

  • 00860011175803 ()


  • Radiology information system

AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEM - 00860010575307

The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software

Vitazi.ai Telehealth Portal - 00860012221608

Vitazi Telehealth Portal is web-facing software used to screen patients for diabetic retinopathy (DR). The Vitazi Telehealth Portal is a software medical device. The purpose of the Vitazi Telehealth Portal is to allow licensed medical providers to review and interpret medical images.
Vitazi.Ai, Inc.
0.0.8
In Commercial Distribution

  • 00860012221608 ()


  • Medical image management system
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