ARGON MEDICAL DEVICES, INC. 049995400E Double Kit

The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI Delivery System enables insertion and placement of two stents in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System.A stent barb cover is provided to facilitate placement of the stent into the endoscope.

BedsAccessories Product Description: 15010 DOUBLE MATT.CVR.W/CONTOUR

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.

Transpac™ IV MONITORING KIT WITH 2 Safeset™ BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT)

FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances.

The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI Delivery System enables insertion and placement of two stents in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System.A stent barb cover is provided to facilitate placement of the stent into the endoscope.

BedsAccessories Product Description: 15010 DOUBLE MATT.CVR.W/CONTOUR