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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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Presto-Scan Evolution - B970ZPKGPRESTOSCANEVOL0

Includes 3140 Sensor installed in Presto-Scan display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, Presto-Scan Software CD with 3140 Map, and Quick Start Guide
Tekscan, Inc.
Presto-Scan System
In Commercial Distribution

  • B970ZPKGPRESTOSCANEVOL0 ()
ZPKG-PRESTOSCAN-EVOLUTION

  • Body-surface pressure mapping system

Norav 1200 Series PC-ECG - 07290110255008

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Driver for P-MP200 Thermal Printer The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW P-MP200
In Commercial Distribution

  • 07290110255008 ()
HASP-SW-K-P1-01

  • Thermal printer

Norav 1200 Series PC-ECG - 07290110252670

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - NER = Event Recording Analysis Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NER
In Commercial Distribution

  • 07290110252670 ()
HASP-SW-K-NER1-01

  • Electrocardiographic long-term ambulatory recording analyser

Norav 1200 Series PC-ECG - 07290110252649

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - L1 = Late Potential Analysis Module The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW L1
In Commercial Distribution

  • 07290110252649 ()
HASP-SW-K-L1-01

  • Cardiovascular risk evaluation interpretive software

Norav 1200 Series PC-ECG - 07290110252618

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - H1 = Heart Rate Variability Analysis The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW H1
In Commercial Distribution

  • 07290110252618 ()
HASP-SW-K-H1-01

  • Cardiovascular risk evaluation interpretive software

Welch Allyn, Inc. - 00732094262896

Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 16 monitoring slots (dual or 24 in. display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262896 ()
SCAC-AEB-CXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094319330

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; No patient cable; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094319330 ()
RSCRIBE-6EC-XXDXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263848

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

Welch Allyn, Inc. - 00732094263794

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

Welch Allyn, Inc. - 00732094263756

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; International power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263756 ()
QS-6AC-DXAXA

  • Electrocardiographic lead set, reusable
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