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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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Includes (2) 3140 Sensors installed in floor display with 2 Evolution Handles, FootMat for Research Software CD with 3140D-1 Map, Help File, and 1 Web-Based Training Session
Tekscan, Inc.
Sports Balance Mat
In Commercial Distribution

  • B970SBMAT0 ()
SBMAT

  • Body-surface pressure mapping system
ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.
NanoEnTek, Inc.
ADAMII
In Commercial Distribution

  • 08809317540627 ()


  • Haematological cell analyser IVD
Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 4 monitoring slots (single display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262919 ()
SCAC-AEB-AXXXX

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 8 monitoring slots (single display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262902 ()
SCAC-AEB-BXXXX

  • Centralized patient monitor
Surveyor Central Review Station - English language and CD manual; 220V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262445 ()
SCREV-AAB-AXXXX

  • Centralized patient monitor
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 - 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 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
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