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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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Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color coding Special edition for GE Health Care.
Norav Medical GmbH
ECGUSB1DEX Kit
In Commercial Distribution

  • 04260498564255 ()
ECGUSB1DEX-K-00-EC3-05

  • Electrocardiographic signal amplifier
Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system.
Braebon Medical Corporation
0585
In Commercial Distribution

  • B14005850 ()
0585

  • Air/gas pressure transducer
Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system.
Braebon Medical Corporation
0584
In Commercial Distribution

  • B14005840 ()

  • Length: 12 Inch
0584

  • Electrode/transducer strap, reusable
  • Air/gas pressure transducer
Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system.
Braebon Medical Corporation
0581L
In Commercial Distribution

  • B1400581L0 ()
0581L

  • Air/gas pressure transducer
Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system.
Braebon Medical Corporation
0581
In Commercial Distribution

  • B14005810 ()
0581

  • Air/gas pressure transducer
Single Channel ECG Acquisition Module for installation in other Medical Devices, such as Cardio-Sonographic Devices. The module has an internal 35Hz Filter and provides Analog Output. Special edition for FMS.
NORAV MEDICAL LTD.
ECGUSB1A
In Commercial Distribution

  • 07290110254247 ()
ECGUSB1A-D-05-02

  • Electrocardiographic signal amplifier
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
TigerView software version 8.4.1
TELEVERE SYSTEMS, LLC
8.4.1
In Commercial Distribution

  • 00851800007108 ()
TigerView 8.4.1

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
TigerView software version 8.2
TELEVERE SYSTEMS, LLC
8.2
In Commercial Distribution

  • 00851800007085 ()
TigerView 8.2

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
ExamVue PACS version 1.1 Build 81
TELEVERE SYSTEMS, LLC
1.1 Build 81
In Commercial Distribution

  • 00851800007078 ()
ExamVue PACS 1.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
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