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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 - 07290110250522

PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labelling
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110250522 ()
1200W2-D-00E-01

  • Electrocardiography telemetric monitoring system transmitter

WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set - 07290110250485

The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessment ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value
NORAV MEDICAL LTD.
PCECG 1200W
In Commercial Distribution

  • 07290110250485 ()


  • Electrocardiography telemetric monitoring system transmitter

Norav 1200 Series PC-ECG - 07290110250195

Kit includes: PC-ECG 1200W (UDI: 07290110250522) wireless Stress-Test Kit Input cable with ten leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
1200W Kit
In Commercial Distribution

  • 07290110250195 ()
1200W2-K-00-E-S10-01

  • Electrocardiography telemetric monitoring system transmitter

Norav 1200 Series PC-ECG - 07290110250157

PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling Special edition for GE Health Care
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110250157 ()
1200W2-D-04U-01

  • Electrocardiography telemetric monitoring system transmitter

Norav 1200 Series PC-ECG - 07290110250140

PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labelling Special edition for GE Health Care
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110250140 ()
1200W2-D-04E-01

  • Electrocardiography telemetric monitoring system transmitter

Sitzmarks Radiopaque Markers - 10610858081020

No Description
KONSYL PHARMACEUTICALS, INC.
Tri-Chamber
In Commercial Distribution

  • 10610858081020 ()
  • 00610858081020 ()


  • Gastrointestinal telemetric monitoring system capsule, non-sterile

Sitzmarks Radiopaque Markers - 10610858081013

No Description
KONSYL PHARMACEUTICALS, INC.
Double D
In Commercial Distribution

  • 10610858081013 ()
  • 00610858081013 ()


  • Gastrointestinal telemetric monitoring system capsule, non-sterile

Sitzmarks Radiopaque Markers - 10610858081006

No Description
KONSYL PHARMACEUTICALS, INC.
Round Hollow
In Commercial Distribution

  • 10610858081006 ()
  • 00610858081006 ()


  • Gastrointestinal telemetric monitoring system capsule, non-sterile

NA - 06970136030216

A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS-1000
In Commercial Distribution

  • 06970136030216 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated

NA - 06970136030100

A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS2000A
In Commercial Distribution

  • 06970136030100 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
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