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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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VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV330
In Commercial Distribution

  • 00865064000157 ()


  • Electrocardiography telemetric monitoring system
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV200
In Commercial Distribution

  • 00865064000119 ()


  • Wireless patient thermometer, reusable
Upper Arm Blood Pressure Monitor
BEURER NORTH AMERICA, L.P.
SBM46
In Commercial Distribution

  • 00852547004962 ()
  • 10852547004969 ()
Type: SBM46/1

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Infrared Lamp
BEURER NORTH AMERICA, L.P.
IL50
In Commercial Distribution

  • 10852547004105 ()
  • 00852547004108 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Portable Nebulizer
BEURER NORTH AMERICA, L.P.
IH50
In Commercial Distribution

  • 20852547004058 ()
  • 10852547004051 ()
  • 00852547004054 ()


  • Ultrasonic nebulizing system
aScope 4 RhinoLaryngo Intervention
Ambu A/S
512101000
In Commercial Distribution

  • 05707480157785 ()
  • 05707480157778 ()
  • 05707480157761 ()

  • Lumen/Inner Diameter: 2 Millimeter
  • Outer Diameter: 5 Millimeter
  • Length: 350 Millimeter
512101000

  • Flexible video otorhinolaryngoscope, single-use
LED Illuminator Used For Surgical Instrument Illumination
ISOLUX LLC
OptiLux
In Commercial Distribution

  • 00852350007020 ()


  • Endoscopic light source unit, line-powered
300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.
ISOLUX LLC
1300XSB
In Commercial Distribution

  • 00852350007006 ()
03-1300XSB

  • Endoscopic light source unit, line-powered
Flexible Cystoscope, Standard Deflection
Ambu A/S
603101000
In Commercial Distribution

  • 05707480164516 ()
  • 05707480164509 ()
  • 05707480164493 ()

  • Lumen/Inner Diameter: 2.2 Millimeter
  • Outer Diameter: 6 Millimeter
603101000

  • Flexible video cystoscope, single-use
Flexible Cystoscope, Reverse Deflection
Ambu A/S
602101000
In Commercial Distribution

  • 05707480164486 ()
  • 05707480164479 ()
  • 05707480164462 ()

  • Outer Diameter: 6 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
602101000

  • Flexible video cystoscope, single-use
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