VYAIRE MEDICAL, INC. AH132 AirLife™

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 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.

SET INCLUDES: - 4100 DRIVER, DUAL-TRIGGER - 4100-125 PIN COLLET - 4100-62 WIRE COLLET - 4103-126 PIN COLLET - 4100-131 JACOBS DRILL - 4100-132 JACOBS DRILL 5/32" - 4103-435 4:1 HUDSON/MODIFIED TRINKLE - 4100-110 SYNTHES DRILL - 4103-110 SYNTHES DRILL -4103-210 SYNTHES REAMER -4103-231 REAMER 1/4" - 4100-400 SAGITTAL SAW - 4100-451 STERILIZATION CONTAINER