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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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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
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
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; US/Canada power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263848 ()
QS-6AC-AXAAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; UK power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 25 in. leadwires with pinch for AM12Q; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263794 ()
QS-6AC-CXBXA

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired 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 25 in. leadwires with pinch for AM12Q; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263732 ()
QS-6AC-XXBXA

  • Cardiopulmonary stress exercise monitoring system computer
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; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8 in.), Q-Stress basic transport cart with base 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

  • 00732094263275 ()
QS-6FC-DEDAX

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress 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; Turnkey system with configured CPU, no display; UK power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; 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

  • 00732094263213 ()
QS-6IB-CGEXB

  • Cardiopulmonary stress exercise monitoring system computer
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
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
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
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