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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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Alpine BioMed - 05704736019477

"Keypoint Focus Module: CN Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701CN
Not in Commercial Distribution

  • 05704736019477 ()


  • Electromyograph

Welch Allyn, Inc. - 00732094332780

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi- clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094332780 ()
XSCRIBE-6CC-DXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094325607

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094325607 ()
HSCRIBE-6AD-ZXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263992

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; No power cord-OUS option only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263992 ()
HSCRIBE-6AC-XXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094259551

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi- clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259551 ()
XSCRIBE-6CC-DXBAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259506

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259506 ()
XSCRIBE-6CC-XXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259131

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259131 ()
XSCRIBE-6GC-DXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259124

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259124 ()
XSCRIBE-6GC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263251

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi- clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263251 ()
QS-6FC-DXDAX

  • Cardiopulmonary stress exercise monitoring system computer

SonarMed AirWave - 00851334007001

AirWave Monitor - Portable/handheld monitor packaged with power transformer and electrical cord, data communication cable, reusable sensor cable, hang strap and software CD.
SONARMED, INC
AW-M0001
In Commercial Distribution

  • 00851334007001 ()


  • Endotracheal secretion monitoring system

SCOTT'S SELECT CLEOID-DISCOID DE # 89-92 - D77812815910

CARVER (1/pack) End: Double End, Size: CD 89-92, Handle: Standard; For more information: https://www.scottsdental.com/catalog/product/view/id/29892/s/carvers-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
128-1591
In Commercial Distribution

  • D77812815910 ()
128-1591

  • Dental restoration carver, multiple-material

SCOTT'S SELECT CLEOID-DISCOID DE # 3-6 - D77812815870

CARVER (1/pack) End: Double End, Size: CD 3-6, Handle: Standard; For more information: https://www.scottsdental.com/catalog/product/view/id/29892/s/carvers-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
128-1587
In Commercial Distribution

  • D77812815870 ()
128-1587

  • Dental restoration carver, multiple-material

Welch Allyn, Inc. - 00732094285413

Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - German language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285413 ()
SCREP-BDB-XXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262483

Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - English language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262483 ()
SCREP-BAB-XXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262476

Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - Italian language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262476 ()
SCREP-BEB-XXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094313802

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094313802 ()
QS-6FC-XXDXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094307085

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094307085 ()
XSCRIBE-6DC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263282

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module; Turnkey system with configured CPU, no display; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263282 ()
QS-6FB-DXEXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263268

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263268 ()
QS-6FC-DGDXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094343410

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094343410 ()
QS-6CC-XXDXA

  • Cardiopulmonary stress exercise monitoring system computer
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