VENTEC LIFE SYSTEMS, INC. PRT-01305-000 VOCSN High Flow Kit

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Ventec High Flow Nasal Cannula Kit contains the following items:- 5x Adult, Valveless Heated Ventec One-Circuit (00855573007235)- 5x Humidifier Bypass (00855573007136)- 5x Optiflow+ Adult Cannula, Medium (09420012429117)- 5x Auto-fill Disposable Adult Humidification Chamber (09420012432025)- 1x High Pressure O2 Hose (14896138006587)- 1x Temperature Probe (09420012401311)- 1x 850 Heater Wire Adapter (09420012421548)- 1x Water Bag Pole (09420012405920)- 1x MR850 Heated Humidifier (09420012407290)