NAVILYST MEDICAL, INC. 46081 BioFlo

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.

BioFlo PICC with Endexo Technology - 5F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)

BioFlo PICC with Endexo Technology - 4F x 55cm Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)

BioFlo PICC with Endexo Technology - 6F x 55cm Triple Lumen Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)

BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit

BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit

NEXIVA 18GA 1.25IN HF Y

Catheter IV Safety 20ga x 1in Straight Radiopaque Polyurethane Pink ProtectIV Plus

Catheter IV Safety 18ga x 1-1/4in Straight Radiopaque Polyurethane Green ProtectIV Plus

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.

BioFlo PICC with Endexo Technology - 5F x 55cm Dual Lumen Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)

BioFlo PICC with Endexo Technology - 4F x 55cm Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)

BioFlo PICC with Endexo Technology - 6F x 55cm Triple Lumen Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)