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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. - 00732094260403

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; Software kit; International power cord; No printer, no transport cart; 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

  • 00732094260403 ()
XSCRIBE-6AC-DXBAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260397

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; 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 + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260397 ()
XSCRIBE-6AC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260380

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; 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

  • 00732094260380 ()
XSCRIBE-6AC-DXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260373

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; 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 + XML Orders + CareFusion CP Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260373 ()
XSCRIBE-6AC-DXBXD

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260335

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; Software kit; No 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

  • 00732094260335 ()
XSCRIBE-6AC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260014

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260014 ()
XSCRIBE-6BC-XXBXC

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259865

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; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259865 ()
XSCRIBE-6CB-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259834

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; US/Canada power cord; No printer, 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

  • 00732094259834 ()
XSCRIBE-6CC-AXAAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259766

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; 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

  • 00732094259766 ()
XSCRIBE-6CC-CEBAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259650

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; 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

  • 00732094259650 ()
XSCRIBE-6CC-DEBAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259643

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; 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; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259643 ()
XSCRIBE-6CC-DEBAC

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259629

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; 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 + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259629 ()
XSCRIBE-6CC-DEBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259421

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; US/Canada power cord; No printer, 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

  • 00732094259421 ()
XSCRIBE-6DC-AXAAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259254

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, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259254 ()
XSCRIBE-6EC-DXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259223

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired 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; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259223 ()
XSCRIBE-6FC-DXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259179

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; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259179 ()
XSCRIBE-6GC-DEBXB

  • Cardiopulmonary stress exercise monitoring system computer

SB Mat Evolution - B970SBMAT0

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 - 08809317540627

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

Welch Allyn, Inc. - 00732094262919

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

Welch Allyn, Inc. - 00732094262902

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

Welch Allyn, Inc. - 00732094262445

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

ACTEON - 03609820553672

The SP Newtron module is a multi-clinic piezo-ultrasonic unit that drives four modes (Perio, Endo, Scaling and "Boost")
SATELEC
SP NEWT. USA CD F00184/1-2-10P
In Commercial Distribution

  • 03609820553672 ()
F55367

  • Ultrasonic dental scaling/debridement system

ACTEON - 03609820027203

The PAM MINILED is a curing light using second generation L.E.D technology. It's one of the only lights able to polymerize almost all types of composite material available today.
SATELEC
MINILED OEM CD P107 OPT OPA7.5
In Commercial Distribution

  • 03609820027203 ()
F02720

  • Dental/surgical polymerization lamp

MCB Series - 00817492021044

No Description
MAR COR PURIFICATION, INC.
MCB 202-100 CD BICARB SNGL SYS
In Commercial Distribution

  • 00817492021044 ()

  • Weight: 125 Pound
  • Height: 61 Inch
  • Depth: 36 Inch
  • Width: 42 Inch


  • Haemodialysis bicarbonate solution preparation mixer

Liofilchem MTS (MIC Test Strip) - 18055182870124

No Description
LIOFILCHEM SRL
Clindamycin CD 0.016-256 100 MTS canister
In Commercial Distribution

  • 08055182870127 ()
  • 18055182870124 ()
920720

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

CONFORMat Evolution - B970CE10

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 - 07290110252595

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

Welch Allyn, Inc. - 00732094302387

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

Welch Allyn, Inc. - 00732094262438

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

Welch Allyn, Inc. - 00732094262414

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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