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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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Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Single User License The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-A1
In Commercial Distribution

  • 07290110252533 ()
HASP-SW-K-NEMS-A-01

  • Patient-administration information system application software
Surveyor Central Review Station - ; English language and CD manual; 220V power; Software kit; No printer; Color LCD 24" monitor with high resolution; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export;
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094314267 ()
SCREV-AAB-BXBAX

  • Centralized patient monitor
X12+ 12-lead Telemetry Transmitter - 608 MHz, graphic display, alkaline battery, carry case, and hookup kit; German language and CD manual; IEC 10-wire, 12-lead LeadForm 38 in. (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901150
Not in Commercial Distribution

  • 00732094283464 ()
X12PLUS-BDB-XXXXX

  • Patient monitoring system module, electrocardiographic
An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains fifty (50) 1.0 ml vials.
STRECK, INC.
213355
In Commercial Distribution

  • 30844509000847 ()
  • 00844509000846 ()

  • Total Volume: 1.0 Milliliter
213355

  • Lymphocyte stabilization reagent IVD
Welch Allyn Spirometer Upgrade for CP 200 Electrocardiograph, includes? Serial Port Adapter / Sensor ?Handle, Pressure Tubing with Connectors, Nose Clip, 4 pack of flow transducer tubes, 3 L calibration syringe, and CD
WELCH ALLYN, INC.
901049
In Commercial Distribution

  • 00732094071030 ()
100400

  • Electrocardiograph, professional, multichannel
PCE-210 PC-Based Exercise Stress System; 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection, treadmill interface cable, stress electrodes and manuals on CD)
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094088649 ()
CPSP-UN-UC-D

  • Diagnostic spirometer, professional
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 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318470 ()
QS-6EC-CBEAB

  • 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; 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 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318463 ()
QS-6EC-CFEAA

  • 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; 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 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318456 ()
QS-6EC-CFEAB

  • 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; 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 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318449 ()
QS-6EC-CFEAC

  • Cardiopulmonary stress exercise monitoring system computer
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