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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. - 00732094308501

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308501 ()
QS-6EC-XXEXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355314

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355314 ()
QS-6AC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094343786

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094343786 ()
QS-6EC-DGEAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308457

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308457 ()
QS-6XC-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094294026

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094294026 ()
QS-6EC-DGEAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259902

XScribe 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; Z200+ thermal printer (includes starter pack of full-grid paper - A4), no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259902 ()
XSCRIBE-6CB-DBAAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259896

XScribe 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, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi- clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259896 ()
XSCRIBE-6CB-DEBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259810

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259810 ()
XSCRIBE-6CC-CDBAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259797

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; 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

  • 00732094259797 ()
XSCRIBE-6CC-CDBAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259704

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; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; 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

  • 00732094259704 ()
XSCRIBE-6CC-DDAAX

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094259681

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; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259681 ()
XSCRIBE-6CC-DDBAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259285

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; 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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259285 ()
XSCRIBE-6EC-DEBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259186

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, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259186 ()
XSCRIBE-6GC-DEBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259070

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU, no display; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259070 ()
XSCRIBE-6HB-DEBAB

  • Cardiopulmonary stress exercise monitoring system computer

Streck Cell Preservative - 10844509000850

An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains two (2) 10ml vials.
STRECK, INC.
213358
In Commercial Distribution

  • 10844509000850 ()
  • 00844509000853 ()

  • Total Volume: 10 Milliliter
213358

  • Lymphocyte stabilization reagent IVD

King Vision Video Laryngoscope Kit - 00612649178073

King Vision Kit consisting of 1 Reusable digital display with video-out port and battery status LED indicator, 3 channeled disposable blades and 1 standard disposable blade (without channel) Educational CD included
King Systems Corporation
KVLKIT3
In Commercial Distribution

  • 00612649178073 ()
  • 00612649182049 ()

  • Adult
KVLKIT3

  • Rigid optical laryngopharyngoscope

Norav 1200 Series PC-ECG - 07290110252694

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-1 to SOFT-NH301-4,Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 DL-Rv to 301
In Commercial Distribution

  • 07290110252694 ()
HASP-SW-KNH300-1-UP-1

  • Electrocardiographic long-term ambulatory recording analyser

Norav 1200 Series PC-ECG - 07290110252632

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I2
In Commercial Distribution

  • 07290110252632 ()
HASP-SW-K-I2-01

  • Patient-administration information system application software
  • Cardiopulmonary stress exercise monitoring system computer
  • Cardiovascular risk evaluation interpretive software

Welch Allyn, Inc. - 00732094319743

Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 8 monitoring slots (single display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094319743 ()
SCAC-AAA-BXCXX

  • Centralized patient monitor

Philips SureSigns Central - 00884838039056

"SureSigns Central Monitoring System for connectivity to SureSigns VM patient monitors, single or dual display support Includes PC with software installed, SW CD, license key, speakers, mouse, keyboard optional :printer, switch"
Philips Medical Systems Hsg
Philips SureSigns Central
In Commercial Distribution

  • 00884838039056 ()
863291

  • Centralized patient monitor
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