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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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The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution

  • B595L2050R0 ()
  • B595L2050R1 ()
  • B595L2050R2 ()
L2050R

  • Pulse oximeter probe, reusable
  • Pulse Co-oximeter probe, reusable
Smoke Aspiration Tip
IMPLANTECH ASSOCIATES, INC.
SE-100
In Commercial Distribution

  • M724SE100102 ()
  • M724SE1001 ()
  • M724SE100252 ()
SE-100

  • Surgical plume evacuation system tube
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-S
In Commercial Distribution

  • B090E20130S1 ()
  • B090E20130S0 ()
  • B090E20130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-S

  • Vascular microcatheter
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-B
In Commercial Distribution

  • B090E20130B1 ()
  • B090E20130B0 ()
  • B090E20130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-B

  • Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-S
In Commercial Distribution

  • B0902P0130S1 ()
  • B0902P0130S0 ()
  • B0902P0130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-S

  • Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-B
In Commercial Distribution

  • B0902P0130B1 ()
  • B0902P0130B0 ()
  • B0902P0130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-B

  • Vascular microcatheter
No Description
OPHTHALMED LLC
B62B213
Not in Commercial Distribution

  • M735B62B2135 ()
  • M735B62B2131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62A413
Not in Commercial Distribution

  • M735B62A4135 ()
  • M735B62A4131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62A313
Not in Commercial Distribution

  • M735B62A3135 ()
  • M735B62A3131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62A213
Not in Commercial Distribution

  • M735B62A2135 ()
  • M735B62A2131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
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