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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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LIOFILCHEM SRL
Clindamycin CD 0.016-256 100 MTS canister
In Commercial Distribution

  • 08055182870127 ()
  • 18055182870124 ()
920720

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
Includes 1 Evolution Handle, CONFORMat Clinical Software CD with CONFORMat Map, (1) 5330 Sensor, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 System
In Commercial Distribution

  • B970CE10 ()
CE1

  • Body-surface pressure mapping system
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - HL7 Integration Engine The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NHL7
In Commercial Distribution

  • 07290110252595 ()
HASP-SW-K-NHL7IE-01

  • Medical equipment clinical data interfacing software
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
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
Surveyor Central Review Station - Italian 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

  • 00732094262407 ()
SCREV-AEB-BXXAX

  • Centralized patient monitor
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - French language and CD manual; 110V power; 0; Color LCD 24 in. monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094302387 ()
SCREP-BCA-XXBXX

  • Centralized patient monitor
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; 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 ; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263398 ()
QS-6EB-DXEXB

  • 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; US/Canada 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

  • 00732094263350 ()
QS-6EC-AXDXA

  • 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 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 ; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263237 ()
QS-6GC-DXEXB

  • Cardiopulmonary stress exercise monitoring system computer
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