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Cook Group Incorporated


Web: http://www.cookgroup.com
Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
Phone: +1-(812)-339-2235, 800-457-4500 | Fax: +1-(800)-554-8335 | Map/Directions >>
 
 

Profile: Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blocker set allows one-lung ventilation using a conventional endotrachael tube and a pediatric fiberoptic bronchoscope. Our central venous catheter sets & trays are used for venous pressure monitoring, blood sampling and administration of drugs & fluids.

The company has ~340 employees and is ISO 9000, CE certified.

FDA Registration Number: 1820334

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• Burn Care First Aid Kits
• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290)
A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210)
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
• Cardiovascular Biopsy Needle (FDA Code: DWO / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Cardiovascular Intravascular Filter (FDA Code: DTK / 870.3375)
A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.
• Cardiovascular Trocar (FDA Code: DRC / 870.1390)
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.
• Catheter Accessories (FDA Code: KGZ / 878.4200)
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
• Catheter Adaptor (FDA Code: GCE / 878.4200)
• Catheter Cannula (FDA Code: DQR / 870.1300)
A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.
• Catheter Connector (FDA Code: GCD / 878.4200)
• Catheter Guide
• Catheter Introducers (FDA Code: DYB / 870.1340)
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
• Catheter Introducers, MULLINS
• Catheter Introducers, Mullins Design
• Catheter Needle (FDA Code: GCB / 878.4200)
• Catheter Punch Instrument (FDA Code: FEX / 876.5090)
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
• Catheter Tip Occluder (FDA Code: DQT / 870.1370)
A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.
• Catheters
• Cement Dispenser (FDA Code: KIH / 888.4200)
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.
• Centimeter Sizing Catheters
• Central Nervous System and Components (FDA Code: JXG / 882.5550)
A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.
• Cervical Biopsy Forceps
• Cervical Caps (FDA Code: HDR / 884.5250)
A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.
• Cholangiography Catheters (FDA Code: GBZ / 878.4200)
• Cholangiography Fixation Clamp
• Closed Tip Ureteral Stent Kit
• Collagen Wound Dressing (FDA Code: KGN)
• Colostomy Appliance
• Connecting Tube
• Continuous Flush Catheter (FDA Code: KRA / 870.1210)
A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.
• Coronary Needle Holders
• Coronary Stent (FDA Code: MAF)
• Cosmetic Surgery, Needle Holder (Serrated)
• Cricothyrotomy Kits (FDA Code: OGP / 868.5800)
A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
• Crile Wood Needle Holder
• Cup Biopsy Forceps
• Curved Carbide Jaw Needle Holder
• Decompression Tube
• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010)
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
• Diagnostic Devices
• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200)
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
• Differential Ventilation Tracheal/Bronchial Tube (FDA Code: CBI / 868.5740)
A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.
• Disposable Biopsy Forceps
• Disposable Colostomy Appliance (FDA Code: EZS / 876.5900)
An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.
• Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ / 876.5630)
(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.
• Disposable Surgical Instrument (FDA Code: KDC / 878.4800)
• Disposable Surgical Instrument Kit (FDA Code: KDD / 878.4800)
• Dissecting Biopsy Forceps
• Double Lumen Tube for Intestinal Decompression (FDA Code: FEG / 876.5980)
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
• Double Pigtail Ureteral Stent Set

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