CAREFUSION 2200, INC PIG1260K Safe-T-Centesis

AR-11910SR: Grasper, Mini Straight Tip, ø2.75 mm 15° Up Curved Shaft w/SR Handle AR-13600SR: Grasper, Alligator Hook Tip, ø4.2 mm, Straight Shaft w/SR Handle AR-12500SR: Grasper, Blunt Straight Tip, ø3.4 mm Straight Shaft w/SR Handle AR-11200: Punch, Large 2.75 mm, Straight Shaft AR-12000: Punch, Standard Straight Tip, ø3.4 mm Straight Shaft AR-12240: Punch, WideBiter 15° Up Tip, ø3.4 mm Straight Shaft AR-12241: Punch, WideBiter 15° Up Tip, ø3.4 mm 15° Up Curved Shaft AR-12530: Punch, Medium Reverse Straight Tip, ø3.4 mm Straight Shaft AR-12800: Punch, Medium 45° Right Angled Tip, ø3.4 mm Straight Shaft AR-12810: Punch, Medium 45° Left Angled Tip, ø3.4 mm Straight Shaft AR-12912: Punch, WideBiter 90° Right Rotary Tip, 3.4 mm Straight Shaft AR-12913: Punch, WideBiter Rotary 90° Left Tip, ø3.4 mm Straight Shaft AR-12950: Punch, Rotary with Scoop 90° Left Tip, ø3.4 mm Straight Shaft AR-12940: Punch, Rotary with Scoop 90° Right Tip, ø3.4 mm Straight Shaft

Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.

Gri-fill Peristaltic Set is an IV fluid transfer set to be used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one source substance is channeled repeatedly to an IV container. It consists of a silicone tube linking a male luer-lock connector and a spike (with a 0.2 µm hydrophobic air filter), and a female luer-lock connection.

GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions.

Safe-T-Centesis 6 Fr Catheter Drainage Tray

Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

Amplatz Type Renal Dilator/Sheath Set

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.

AR-11910SR: Grasper, Mini Straight Tip, ø2.75 mm 15° Up Curved Shaft w/SR Handle AR-13600SR: Grasper, Alligator Hook Tip, ø4.2 mm, Straight Shaft w/SR Handle AR-12500SR: Grasper, Blunt Straight Tip, ø3.4 mm Straight Shaft w/SR Handle AR-11200: Punch, Large 2.75 mm, Straight Shaft AR-12000: Punch, Standard Straight Tip, ø3.4 mm Straight Shaft AR-12240: Punch, WideBiter 15° Up Tip, ø3.4 mm Straight Shaft AR-12241: Punch, WideBiter 15° Up Tip, ø3.4 mm 15° Up Curved Shaft AR-12530: Punch, Medium Reverse Straight Tip, ø3.4 mm Straight Shaft AR-12800: Punch, Medium 45° Right Angled Tip, ø3.4 mm Straight Shaft AR-12810: Punch, Medium 45° Left Angled Tip, ø3.4 mm Straight Shaft AR-12912: Punch, WideBiter 90° Right Rotary Tip, 3.4 mm Straight Shaft AR-12913: Punch, WideBiter Rotary 90° Left Tip, ø3.4 mm Straight Shaft AR-12950: Punch, Rotary with Scoop 90° Left Tip, ø3.4 mm Straight Shaft AR-12940: Punch, Rotary with Scoop 90° Right Tip, ø3.4 mm Straight Shaft

Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.

Gri-fill Peristaltic Set is an IV fluid transfer set to be used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one source substance is channeled repeatedly to an IV container. It consists of a silicone tube linking a male luer-lock connector and a spike (with a 0.2 µm hydrophobic air filter), and a female luer-lock connection.

GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions.