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Address: 2000 Hollister Drive, Libertyville, Illinois 60048, USA
www.hollister.com |
Phone: +1-(847)-680-1000
FDA Registration: 1480288 Year Established: 1921
Quality: ISO 9002, CE Certified
Products: Breast Pumps, Urethral Catheters (FDA Code:
GBM), Urinary Leg Bags, Urine Collection Leg Bags (FDA Code:
FAQ), Cotton & Rayon Dressings, Ostomy Drain Pouches, ...
Hollister Incorporated delivers products for ostomy, wound care, incontinence & continence care, breastfeeding, patient identification, medical records, obstetrics and cold therapy. Our product Pouchk
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Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com |
Send Inquiry |
Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001
Annual Revenues: USD 50-100 Million
Employee Count: ~230
Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code:
BYG), Fetal Monitors, Vaginal Retractors (FDA Code:
HDL), Forceps (FDA Code:
HTD), Probes (FDA Code:
HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l
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Address: 10565, S.E., 23rd Avenue, Milwaukie, Oregon 97222, USA
Phone: +1-(503)-659-5517
Products: Stomal Bag (FDA Code:
GDS), Ostomy Drainage Bag (FDA Code:
FON), Disposable Colostomy Appliance (FDA Code:
EZS), Ileostomy Urinary Bag (FDA Code:
EXH), Ostomy Collector (FDA Code:
EXB), ...
Remedy, Inc. offers ostomy collectors, ileostomy urinary bags and stomal bags.
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Address: Halifax Rd., Cressex Industrial Estat, High Wycombe, Bucks. HP12 3NB, United Kingdom
Phone: +44-(1494)-532-761
Employee Count: ~150
Quality: ISO 9000, CE Certified
Products: Masks & Breathing Bags, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code:
FAQ), Urinary Leg Bags, Vented Urinary Leg Bag System, Sterile Leg Urine Collection Bag for External Use (FDA Code:
FAQ), ...
Rusch (UK) Ltd. supplies a broad range of invasive & noninvasive, disposable and reusable devices to the anesthesiology, urology, gastroenterology, and respiratory care markets. We offer various urolo
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Address: Holtedam 1, Humlebaek DK-3050, Denmark
www.coloplast.com |
Send Inquiry |
Phone: +45-(0)-4911-1111
FDA Registration: 9610694 Year Established: 1957
Annual Revenues: USD 100-500 Million
Employee Count: ~7000
Quality: CE Certified
Products: Urethral Catheters (FDA Code:
GBM), Urine Collection Leg Bags (FDA Code:
FAQ), Straight Catheter (FDA Code:
EZD), Urological Catheters (FDA Code:
KOD), Penile Prosthesis (FDA Code:
FAE), Sterile Leg Urine Collection Bag for External Use (FDA Code:
FAQ), ...
Coloplast A/S develops products and services that make life easier for people with very personal & private medical conditions. Our business includes ostomy care, urology & continence care, and wound &
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Address: Av Cordillera 451, Santiago, Chile
Phone: +56-(2)-756- 9600
Products: Connecting Flexible Aspirating Tube (FDA Code:
BYY), General & Plastic Surgery Ventricular Catheter (FDA Code:
GBS), Irrigation Catheter (FDA Code:
GBX), Non-Powered Portable Single Patient Suction Apparatus (FDA Code:
GCY), Stomal Bag (FDA Code:
GDS), Electroconductive Media (FDA Code:
GYB), ...
Primus Medical S.A. specializes in manufacturing medical devices. We also export disposable medical devices. Our products are drainage systems with pouches, suction tubes, intracranial devices, ethyle
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FDA Code / Regulation: GDS / 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.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 876.9.