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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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TIMS System - 00850951007463

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 41M
Not in Commercial Distribution

  • 00850951007463 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007449

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 40M
Not in Commercial Distribution

  • 00850951007449 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

Norav 1200 Series PC-ECG - 07290110252663

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - M1 = Continuous Resting-ECG Monitoring The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW M1
In Commercial Distribution

  • 07290110252663 ()
HASP-SW-K-M1-01

  • Patient monitoring system module, electrocardiographic, long-term recording

Norav 1200 Series PC-ECG - 07290110252625

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I1 = Resting-ECG Measurement Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I1
In Commercial Distribution

  • 07290110252625 ()
HASP-SW-K-I1-01

  • Cardiovascular risk evaluation interpretive software

Welch Allyn, Inc. - 00732094263008

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; None; No power cord; No printer; No accessories; No patient cable; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263008 ()
RSCRIBE-6EX-XXDXX

  • Electrocardiograph, professional, multichannel

Summit Doppler - 00888937011364

Vantage ABI System Contents: Two 10cm cuffs, two 12cm cuffs, four color-coded hoses; reporting software CD, USB memory stick, roll stand with basket, ABI report forms and built-in printer.
Coopersurgical, Inc.
VANMAX
In Commercial Distribution

  • 00888937011364 ()


  • Noninvasive vascular ultrasound system

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

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

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

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. - 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. - 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. - 00732094320268

XScribe 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; Z200+ thermal printer, (includes starter pack of full-grid paper - 8"), XScribe premium transport cart with base, keyboard tray, storage shelf, large storage drawer, and side storage pocket; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094320268 ()
XSCRIBE-6CC-XFAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308723

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; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and 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

  • 00732094308723 ()
QS-6CC-DFCXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308501

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; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; 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

  • 00732094308501 ()
QS-6EC-XXEXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308457

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; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; 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

  • 00732094308457 ()
QS-6XC-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094294026

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; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; 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

  • 00732094294026 ()
QS-6EC-DGEAA

  • 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

Welch Allyn, Inc. - 00732094263541

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired Acquisition Module; Turnkey system with configured CPU, no display; UK power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263541 ()
QS-6CB-CXCAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263534

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Turnkey system with configured CPU, no display; UK power cord; No printer, no transport cart; IEC 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) HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263534 ()
QS-6CB-CXCXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263329

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; No power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; 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

  • 00732094263329 ()
QS-6EC-XGDAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355314

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired 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 43" leadwires with pinch for AM12Q; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355314 ()
QS-6AC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260854

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; Turnkey system with configured CPU, no display; 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; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260854 ()
XSCRIBE-6AB-CEBAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260786

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; Turnkey system with configured CPU, no display; International 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

  • 00732094260786 ()
XSCRIBE-6AB-DXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260649

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; 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

  • 00732094260649 ()
XSCRIBE-6AC-CEBAB

  • Cardiopulmonary stress exercise monitoring system computer
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