AQUEDUCT CRITICAL CARE, INC. ACC-KIT-100 Aqueduct SED

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.

CODMAN® HAKIM® Programmable Valve with Unitized Large RICKHAM® Reservoir and Non-Unitized Distal Catheter 120cm Operating Pressure: 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Programmable in steps of 10mm H2O (98 Pa)

CODMAN® HAKIM® Programmable Valve Right Angle Valve Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa)

CODMAN HAKIM Programmable Valve Right Angle Valve with SIPHONGUARD Device Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Programmable Valve, Information Manual and Priming Adapter

CODMAN® HAKIM® Programmable Valve In-Line Valve Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa)

CODMAN HAKIM Programmable Valve In-Line Valve SIPHONGUARD Device, .060 Inch Platform and Unitized Distal Catheter Operating Pressure: 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) programmable in steps of 10mm H2O (98 Pa) Includes: Ventricular Catheter 14cm, Stylet, Right Angle Adaptor, Straight Connector, HOLTER Type B Connector, Priming Adaptor and Information Manual

Burr, Oval, 10 flute, 3.0mm

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.