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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. - 00732094259575

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, no transport cart; 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

  • 00732094259575 ()
XSCRIBE-6CC-DXBAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259544

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, 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

  • 00732094259544 ()
XSCRIBE-6CC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259391

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; 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

  • 00732094259391 ()
XSCRIBE-6DC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259148

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, 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

  • 00732094259148 ()
XSCRIBE-6GC-DXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259100

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; No 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

  • 00732094259100 ()
XSCRIBE-6GC-XXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn - 04041346032405

No Description
IEM GmbH
HMS WA CD 5.0 CBP
Not in Commercial Distribution

  • 04041346032405 ()


  • Blood pressure ambulatory recorder

ACTEON - 03609820554433

The SP Newtron module is a multi-clinic piezo-ultrasonic unit that drives four modes (Perio, Endo, Scaling and "Boost")
SATELEC
SP NEWTRON ASI CD LG2.07
In Commercial Distribution

  • 03609820554433 ()
F55443

  • Ultrasonic dental scaling/debridement system

ACTEON - 03609820052052

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
ML OEM SUPERCHARGED CD LG
In Commercial Distribution

  • 03609820052052 ()
F05205

  • Dental/surgical polymerization lamp

Cercon® - EDD153673619120

No Description
DeguDent GmbH
Cercon ht Body-base C-D 12g
Not in Commercial Distribution

  • EDD153673619120 ()

  • Weight: 12 Gram
5367361912

  • Dental appliance fabrication material, ceramic

BUSCH®, BNA® - D8120323461

Cool diamond
BUSCH & CO. GmbH & Co. KG
CD 72G 012 COOL-DIA FG
In Commercial Distribution

  • D8120323460 ()
  • D8120323461 ()
032346

  • Diamond dental bur, reusable

BUSCH®, BNA® - D8120320451

Cool diamond
BUSCH & CO. GmbH & Co. KG
CD 12 018 COOL-DIA FG
In Commercial Distribution

  • D8120320450 ()
  • D8120320451 ()
032045

  • Diamond dental bur, reusable

BUSCH®, BNA® - D8120320401

Cool diamond
BUSCH & CO. GmbH & Co. KG
CD 12 016 COOL-DIA FG
In Commercial Distribution

  • D8120320400 ()
  • D8120320401 ()
032040

  • Diamond dental bur, reusable

TIMS System - 00850951007241

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 32L
Not in Commercial Distribution

  • 00850951007241 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007180

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 30K
Not in Commercial Distribution

  • 00850951007180 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007012

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 25J
Not in Commercial Distribution

  • 00850951007012 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007326

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 32M
Not in Commercial Distribution

  • 00850951007326 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007210

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 31K
Not in Commercial Distribution

  • 00850951007210 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007159

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 29K
Not in Commercial Distribution

  • 00850951007159 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007128

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 28K
Not in Commercial Distribution

  • 00850951007128 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007081

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 27K
Not in Commercial Distribution

  • 00850951007081 ()
061000-2000

  • Radiology picture archiving and communication system workstation

Welch Allyn, Inc. - 00732094285475

Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; Custom display and control (Project Management required); No printer; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285475 ()
SCAC-AEB-EXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094260359

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; No lead set; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260359 ()
XSCRIBE-6AC-DXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260755

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; US/Canada power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260755 ()
XSCRIBE-6AC-AXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260748

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; US/Canada power cord; No printer, no transport cart; No lead set; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260748 ()
XSCRIBE-6AC-AXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094299977

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; No 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

  • 00732094299977 ()
QS-6FC-XXDAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094285994

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; 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

  • 00732094285994 ()
QS-6FC-DXDAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308716

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308716 ()
QS-6CC-DGCXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094307245

Q-Stress 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, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094307245 ()
QS-6FB-DGEXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094300383

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; 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; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094300383 ()
XSCRIBE-6DC-DXBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094296297

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094296297 ()
HSCRIBE-6AA-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094259780

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; 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

  • 00732094259780 ()
XSCRIBE-6CC-CEAAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259742

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, no transport cart; IEC 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

  • 00732094259742 ()
XSCRIBE-6CC-CXBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259636

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

  • 00732094259636 ()
XSCRIBE-6CC-DEBAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259612

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 + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259612 ()
XSCRIBE-6CC-DEBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259582

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, no transport cart; IEC 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

  • 00732094259582 ()
XSCRIBE-6CC-DXBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259568

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, no transport cart; 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

  • 00732094259568 ()
XSCRIBE-6CC-DXBAC

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259407

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

  • 00732094259407 ()
XSCRIBE-6DC-DEBAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259162

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

  • 00732094259162 ()
XSCRIBE-6GC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259155

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, 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

  • 00732094259155 ()
XSCRIBE-6GC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259117

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; No 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

  • 00732094259117 ()
XSCRIBE-6GC-XXBXA

  • Cardiopulmonary stress exercise monitoring system computer

TIMS System - 00850059977392

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 53S
In Commercial Distribution

  • 00850059977392 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977347

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 52R
In Commercial Distribution

  • 00850059977347 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977293

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 52S
In Commercial Distribution

  • 00850059977293 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977255

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 51R
Not in Commercial Distribution

  • 00850059977255 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977187

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 51Q
Not in Commercial Distribution

  • 00850059977187 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977163

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 51P
Not in Commercial Distribution

  • 00850059977163 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977118

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 50P
Not in Commercial Distribution

  • 00850059977118 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977033

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 50O
Not in Commercial Distribution

  • 00850059977033 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007982

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 49O
Not in Commercial Distribution

  • 00850951007982 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007951

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 48O
Not in Commercial Distribution

  • 00850951007951 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation
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