NAVILYST MEDICAL, INC. 45458 Vaxcel

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.

2108 Series Sagittal Blade (28.9 x 0.64 x 58.7mm)

Precision Thin Offset (10.0 x 0.38 x 43.0mm)

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)

Catheter Placement Kit

PowerPICC Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer

PowerPICC FT Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 5F Maximal Barrier Tray

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

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.

2108 Series Sagittal Blade (28.9 x 0.64 x 58.7mm)

Precision Thin Offset (10.0 x 0.38 x 43.0mm)